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CSL
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  • The Global Category Lead for Labs & Manufacturing Supplies, Filtration... Read More
    The Global Category Lead for Labs & Manufacturing Supplies, Filtration & Single Use Technology (SUT) is a strategic category leader responsible for executing CSL’s sourcing strategy across a regulated, operationally critical portfolio of approximately USD $90M in annual spend across ~1,000 suppliers. The role directly supports Laboratory and Manufacturing Raw Material requirements, including critical materials for quality testing, validation, and final product release, ensuring compliant, efficient, and scalable procurement strategies aligned with enterprise priorities and operational objectives.The Global Category Lead develops category strategies and supplier governance frameworks to drive financial performance, simplify the portfolio, and strengthen supply continuity. The role ensures consistent use of approved suppliers, catalogs, and contracts, minimizing off-channel spend and maximizing network-wide sourcing leverage. By standardizing and simplifying buying processes, the role enhances supply reliability, mitigates operational and regulatory risk, and improves the procurement experience.This role leads supplier consolidation and standardization initiatives to reduce complexity and validation burden for process-critical materials. In partnership with Supply Chain and Operations, the role optimizes Vendor Managed Inventory (VMI) and replenishment models, balancing working capital efficiency with uninterrupted supply to maintain operational continuity across multiple sites.The Sourcing Lead ensures sourcing strategies comply with GMP, regulatory, and technical requirements through close collaboration with Quality, Operations, Supply Chain, and R&D. The role also drives the ongoing alignment of the strategic roadmap with long-term enterprise objectives. In addition, the Associate Director builds team capability, provides mentorship, and develops future procurement leaders to sustain performance and resilience across the network.RESPONSIBILITIES1. Category Strategy & GovernanceDefine and execute category strategies for Labs & Manufacturing Supplies, Filtration & Single Use Technology (SUT) aligned to CSL’s operational, quality, and regulatory requirements and managing an annual spend of approximately USD 90M.Establish and govern sourcing frameworks, standards, and commercial guardrails that enable compliant, scalable, and efficient procurement across the CSL network.Maintain oversight of supplier segmentation, specification standardisation, and lifecycle management for process-critical materials.2. Demand Channelling & Procurement ComplianceOwn demand channeling to preferred buying routes and approved procurement channels, ensuring consistent utilisation of approved suppliers, catalogs, and contracts.Govern supplier and contract adherence to reduce maverick spend, minimise local variability, and maximise network-wide spend leverage.Drive consistent adoption of sourcing strategies across sites through clear governance, stakeholder engagement, and change management.3. Supplier Consolidation & Risk ManagementLead supplier consolidation and standardisation initiatives to reduce portfolio complexity and minimise qualification and validation burden.Strengthen supply assurance and continuity for materials critical to manufacturing, testing, validation, and final product release.Proactively identify and mitigate supply, quality, and compliance risks in partnership with Quality and Operations.4. Inventory & VMI OptimisationLead the optimisation of Vendor Managed Inventory (VMI) and replenishment models in collaboration with Supply Chain and site Operations.Balance working capital efficiency with service levels and uninterrupted supply, aligned to demand variability and material criticality.5. Cross-Functional Partnership & Regulatory AlignmentAct as a strategic business partner to Quality, Operations, Supply Chain, and R&D.Ensure sourcing strategies align with GMP-aligned sourcing practices, regulatory expectations, and audit readiness requirements.Support change control, material qualification, and validation activities through disciplined supplier and specification management.6. Performance, Value & Continuous ImprovementDeliver measurable outcomes across cost efficiency, spend leverage, supply reliability, and risk reduction.Improve cycle times, process consistency, and user experience by simplifying procurement pathways and enabling ease of execution for the business.Monitor category performance using defined KPIs and continuously refine sourcing approaches to support CSL’s operational performance and growth objectives.Education RequirementsBachelor’s degree in business, Supply Chain, or related discipline; MBA or advanced degree preferred.Experience RequirementsMinimum 10+ years’ experience in strategic sourcing, category management, or procurement leadership roles, preferably within the pharmaceutical, biopharmaceutical, or highly regulated manufacturing sectors.Proven experience leading cross-functional teams and collaborating with Quality, Operations, Supply Chain, and R&D.Demonstrated success in developing and executing category strategies that deliver measurable value, cost efficiency, and supply continuity across complex networks.Experience in supplier consolidation, governance frameworks, and Vendor Managed Inventory (VMI) optimization.Track record of managing complex supplier relationships while maintaining compliance with regulatory requirements, including GMP-aligned sourcing practices.Experience in change management, stakeholder engagement, and driving adoption of standardized procurement pathways across multiple sitesCompetencies Strategic Thinking: Ability to develop and implement long-term category strategies that balance cost, supply risk, and regulatory compliance while supporting CSL’s operational and growth objectives.Leadership and Team Management: Provides effective leadership, coaching, and mentoring to Category Managers and cross-functional partners, fostering a collaborative, high-performance culture.Supplier Relationship Management: Builds and maintains strategic, value-focused relationships with suppliers to enhance collaboration, drive innovation, and ensure supply continuity for critical materials.Negotiation and Commercial Acumen: Applies expert negotiation and contracting skills to secure favourable terms, enforce compliance, and optimise network-wide spend leverage.Process and Continuous Improvement: Identifies opportunities to streamline procurement pathways, standardise frameworks, optimise VMI, reduce complexity, and improve cycle time and user experience.Regulatory & Quality Alignment: Ensures sourcing strategies and supplier practices comply with GMP requirements and support audit readiness, validation, and product release processes.Influence without Direct Authority: Effectively drives adoption of category strategies, governance, and supplier standards across sites and functions through collaboration and stakeholder engagement.Working ConditionsAbility to work across time zones and manage global stakeholder relationshipsTravel Requirements (Domestic, International, frequency)Domestic travel as required (maximum 30%)International travel as required (maximum 20%)About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
    CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Category Lead - Pre- & clinical Supply  

    - Liverpool
    The Global Sourcing Lead for Clinical and Pre Clinicals Supply is a st... Read More
    The Global Sourcing Lead for Clinical and Pre Clinicals Supply is a strategic category leader responsible for executing CSL’s sourcing strategy across a highly regulated, new product development portfolio supporting the CSL R&D pipeline and new product introduction. The role directly clinical development and supply requirements, including critical vendors for quality testing, validation, and development studies, ensuring compliant, efficient, and scalable procurement strategies aligned with enterprise priorities and operational objectives.The Global Sourcing Lead develops category strategies and supplier governance frameworks to drive financial performance, simplify the portfolio, and strengthen supply continuity. The role ensures consistent use of approved suppliers, catalogs, and contracts, minimizing off-channel spend and maximizing network-wide sourcing leverage. By standardizing and simplifying buying processes, the role enhances supply reliability, mitigates operational and regulatory risk, and improves the procurement experience.This role leads market screening and partnership development, supplier consolidation and standardization initiatives to reduce complexity and validation burden for critical materials and services. In partnership with Tech Operations, Supply Chain and Operations, the role optimizes support and supply models.The Sourcing Lead ensures sourcing strategies comply with GMP, regulatory, and technical requirements through close collaboration with R&D, Tech Ops, Quality, Operations and Supply Chain. The role also drives the ongoing alignment of the strategic roadmap with long-term enterprise objectives. In addition, the Associate Director builds team capability, provides mentorship, and develops future procurement leaders to sustain performance and resilience across the network.RESPONSIBILITIESSourcing strategy developmentLead the development and execution of long-term category strategies aligned with enterprise objectives.Collaborate globally across business units to influence senior leaders and advocate for key business improvement programs.Develop business cases to gain endorsement for value-driving initiatives.Lead annual opportunity analysis forums with cross-functional stakeholders and supplier partners to replenish initiative pipelines.Act as a conduit for external innovation, facilitating workshops to solve complex business challenges through supplier partnerships.Team leadershipManage and mentor a team of Category Managers, fostering a high-performance and collaborative culture.Develop workforce plans and succession strategies to ensure team capability and continuity.Provide coaching and support for professional development and performance improvement.Lead initiatives to enhance procurement capabilities and deliver sustained value.Category management strategyDrive continuous improvement in sourcing processes, tools, and methodologies.Build strategic relationships with key suppliers to enhance collaboration, performance, and innovation.Lead negotiations to secure favourable terms while maintaining strong partnerships.Monitor supplier performance and ensure alignment with contractual obligations and business expectationsPolicy and governance managementEnsure adherence to procurement policies, governance frameworks, and compliance standards.Manage procurement-related risks and implement mitigation strategies.Oversee budget planning and financial management within assigned categories.Performance monitoringMonitor performance of category strategies in achieving value creation and delivery KPIsProvide regular reporting and insights to executive leadership on category performance and strategic initiatives.Cross-functional collaborationPartner with Finance BPs, Operational Excellence, and Procurement Business Partners to align category strategies with business needs.Develop tailored communications for diverse audiences to manage change, resolve conflict, and build consensus.Other responsibilitiesMarket analysis.Budget management.Continuous improvement.Reporting and communication.Risk management.Training and development.Education RequirementsBachelor’s degree in business, Supply Chain, or related discipline; MBA or advanced degree preferred.Experience RequirementsMinimum 8+ years’ experience in strategic sourcing, category management, or procurement leadership roles.Preferable 3+ years demonstrated clinical trial supply sourcing experienceProven experience in leading cross-functional teams and managing complex supplier relationships.Demonstrated success in developing and executing category strategies and delivering measurable value.Understanding of pharma and biotech clinical pipeline management / Chemistry, Manufacturing, and Controls (CMC)Experience in change management, stakeholder engagement, and innovation facilitation.CompetenciesStrategic Thinking: Ability to develop and implement long-term category strategies that align with organisational objectives and drive measurable value.Leadership and Team Management: Demonstrates strong leadership to effectively manage, mentor, and inspire a team of Category Managers, fostering a collaborative and high-performance cultureSupplier Relationship Management: Builds and maintains strategic relationships with suppliers to enhance collaboration, drive innovation, and deliver sustained value.Negotiation Skills: Applies exceptional negotiation techniques to secure favourable terms while preserving strong supplier partnerships.Continuous Improvement: Proactively identifies opportunities to improve procurement processes, tools, and outcomes to enhance efficiency and effectiveness.Project Management Skills: Plans tasks, assigns resources, manages progress, removes barriers, manages change, resolves conflict, builds consensus, and motivates team members across multiple projects concurrently.Working ConditionsAbility to work across time zones and manage global stakeholder relationshipsTravel Requirements (Domestic, International, frequency)20%About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
    CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Director, Search & Evaluation Early TA Lead  

    - Maidenhead
    Two Directors of Search & Evaluation to lead strategic sourcing and ev... Read More
    Two Directors of Search & Evaluation to lead strategic sourcing and evaluation of external innovation opportunities in Hematology, and Cardiovascular/Renal therapeutic areas. Embedded within each Therapeutic Area Leadership Team (TALT), these leaders will identify and advance high-potential assets from preclinical through Phase 1 clinical stages, shape early partnering strategies, and drive transactions in collaboration with Business Development​MainResponsibilities & Accountabilities​Serve as the senior Early S&E leader within the TALT, influencing therapeutic strategy and ensuring external innovation priorities are integrated into portfolio planning.​Lead proactive sourcing and scouting efforts for preclinical and Phase 1 assets, building a robust pipeline of opportunities aligned with TA strategy.​Co-lead internal meetings (with Late Search Lead) focused on evaluating and prioritizing New Product Opportunities (NPOs) within each CSL’s therapeutic areas. NPO meetings are strategic checkpoints where cross-functional teams review potential assets identified by Search and decide whether to advance them for further due diligence and deal negotiations​Develop and execute early partnering strategies, including onboarding approaches and competitive positioning for priority assets.​Drive cross-functional due diligence for each opportunity, coordinating scientific, clinical, regulatory, and commercial assessments to inform governance decisions.​Transaction Execution: Partner closely with BD and Regional Ecosystem Leads to advance high-priority opportunities through negotiation and deal close, ensuring seamless handoff and execution​Represent the TA externally, leading sourcing activities at specialized conferences and cultivating relationships with biotech, academia, and investment communities.​Qualifications & Experience Requirements​Significant tenure in biopharma with significant experience in external innovation, search & evaluation, or business development.​Advanced degree required (PhD, MD, or equivalent).​Must have Deep scientific expertise in Hematology or Cardiovascular/Renal therapeutic areas.​Proven track record of leading due diligence and closing early-stage deals.​Strong network within biotech, academia, and pharma BD organizations.​About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
    CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Head of Pharmacovigilance Operations  

    - Maidenhead
    CSL is transforming its R&D organization to accelerate innovation and... Read More
    CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.Could you be our next Head of Pharmacovigilance Operations? The job is in our King of Prussia, PA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week.You will be a strategic leader that ensures a lean, agile, and cost-efficient organization that delivers the highest standards of patient safety, while maintaining strict compliance with global regulations. The Head of Pharmacovigilance Operations will develop and implement innovative case management strategies across the Enterprise ensuring compliance with regulatory obligations and scientific excellence. The incumbent will spearhead and oversee strategic outsourcing initiatives, organizational redesign, and implement automation to enhance operational efficiency, data quality, and cost savings.Main responsibilities and accountabilities:Case Management Responsibilities:Oversee end-to-end case processing operations, ensuring high-quality, scientifically accurate, timely, and compliant case management across global PV activities.Monitor regulatory compliance within case processing workflows, ensuring alignment with local and international requirements, including data privacy and governance standards.Drive continuous improvements in case quality and efficiency through operational benchmarking and implementation of best practices.Business Transformation:Lead case processing transformation efforts through strategic outsourcing, automation, and workforce optimization to achieve operational excellence.Partner with HR to implement workforce change initiatives, including role repurposing, employee retraining, and organizational redesign.Develop and execute cost-saving strategies, transitioning PV operations from human-led to technology-driven processesFoster a culture of innovation and continuous improvement to drive long-term organizational agility and adaptability.Intake & Triage:Oversee intake and triage processes, including the adoption of automation solutions for initial case processing stages.Ensure seamless integration of new intake and triage technologies into existing workflows, improving data capture and efficiency.Establish performance metrics and monitoring systems to evaluate the effectiveness of intake and triage operations.Vendor Oversight and Management:Build and maintain strong vendor relationships to ensure high performance, quality, and compliance in outsourced PV operations.Develop and establish an innovative vendor oversight and management model to drive ICSR excellenceDefine and monitor key performance indicators (KPIs) and service-level agreements (SLAs) for vendor performance.Collaborate with vendors to implement quality improvement initiatives and address compliance challenges.Oversee vendor audits and risk assessments to ensure alignment with organizational and regulatory standards.Cross-Functional Collaboration:Collaborate with internal stakeholders, including quality, and clinical teams, to align the case management function with broader organizational goals.Manage and oversee budgets for Case Management, ensuring financial targets and project milestones are achieved.Communicate transformation goals and progress to senior leadership, ensuring alignment with the organization’s strategic vision.Medical Evaluation:Establishment and maintenance of a high performing outsourced medical evaluation functionDirecting the medical evaluation strategy ensuring a consistent, scientifically robust approach embedded in CSL’s signal detection frameworkJob Qualifications and Experience RequirementsBachelor's Degree in a relevant scientific or technical field (e.g., MS, PhD, PharmD) preferred.15+ years in leading multi-year transformation projects, including outsourcing and organizational redesign within PV operations.Profound experience in vendor oversight and management applying innovative approaches to achieve case management excellenceDemonstrated expertise in implementing PV technology solutions, such as intake automation, safety databases, signal detection, literature screening, and risk management.Extensive experience in managing global teams and partnersHands-on experience in vendor management, including negotiating contracts and building large offshore vendor models.About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
    CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Head, PV and Regulatory QA  

    - Maidenhead
    The Head of Pharmacovigilance and Regulatory Quality Assurance leads t... Read More
    The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards. Your role bridges strategic oversight with hands on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business.You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound. You partner with senior leadership on strategic direction, but you're equally engaged in the details that matter—ensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready.The RoleYou will direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates. Your focus is on three core pillars: Strategic Governance, Operational Excellence, and Regulatory Intelligence.Key Accountabilities:Strategic Leadership: Harmonize processes within Global PVRQA and across other GxP areas. Contribute to the larger strategic vision of Global R&D Quality and interact with the Leadership Team to ensure continuous alignment.Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors.Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and 3rd party audits.System Oversight: Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).Cross-Functional Expertise: Provide GVP consultancy and cross-GxP expertise (GCP, GDP, GCLP) to ensure coordination across functional areas, including Commercial and Clinical Development.Operational Management: Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.Resource Stewardship: Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.Continuous Improvement: Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.Your ProfileThe successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system.Qualifications & Experience:Education: Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; an advanced degree is preferred.Industry Tenure: 10+ years of pharmaceutical industry experience specifically within Quality Assurance.Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research.Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions.Leadership Attributes:Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions.Communication & Influence: Excellent communication, negotiation, and influencing skills across all levels of the business.Operational Rigor: Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans.About CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Lead Process Engineer  

    - Liverpool
    This position is responsible for providing technical leadership within... Read More
    This position is responsible for providing technical leadership within the process engineering department for equipment and process design for Seqirus Liverpool’s products ensuring the engineering solutions meet cost, reliability, schedule, and performance integrity requirements. Additionally, this position is responsible for the planning and execution of all process engineering activities from preliminary design to routine manufacturing, coordinated with the project management team, including in-house/plant technical supportResponsibilitiesTo act as Lead Process Engineering SME for support of team members in the identification, investigation and provision of compliant solutions and innovations involving:Process DesignDesign Qualification, Design Review and HAZOP studiesLead Process Safety initiatives across supported areas and wider site, championing improvements and knowledge sharingProcess, equipment & component specification (plant, instrumentation, automation & consumables/disposables)Change control managementInput into budget development and securing of Opex & Capex fundingAutomation approach including the Sequence of Operations and FDS definitionCommissioning, validation and handover (FAT, SAT, FT/Commissioning, IQ, OQ, PQ, CV, CSV)Lead, as a subject matter expert:Working with the cross-function team, consolidate and refine requirements for process equipment and facilities.Responsible for preparing technical specifications throughout the procurement process to ensure that the user requirements are met. Negotiates cost delivery and technical/design feasibility with external suppliers.Responsible for managing delivery, issues and risks arising during the procurement, design, and construction phases of process equipment and facilities.Collaborate with project manager(s) to determine cost, platform and resource requirements in order to deliver projects on time and within budget.Participate in resolution of issues such as conflicting design requirements, unsuitability of standard material and difficult coordination requirements.Coordinate project activities with other operating or engineering units to facilitate participation of appropriate staff in project completion.Assign tasks to process engineering staff and supervise progress to ensure objectives are being met.Monitor resource loading and prioritise activities to maximise the overall business contribution of the department, using agreed tools and metrics as required. Ensure that customer expectations are met for business KPIs and work priorities including:savings targetson time closure of deviations, CAPAs, change controls, MRFs and regulatory commitmentsproject selection & portfolio managementTo advocate, encourage and enthusiastically adopt a culture of participation, knowledge sharing, involvement, and focus on anticipating and preventing potential problems. Maintain an external focus to ensure industry best practices are incorporated into Liverpool Operations and site technical standards. Uphold and contribute to the development of site engineering standards to comply with regulatory and pharmaceutical industry requirements. Ensure that appropriate standards of GMP, housekeeping, safety and discipline are maintained at all times both within the department and operational areas. Participate in professional organizations to maintain current knowledge of technical innovations.Education RequirementsA recognised degree in Chemical/Process Engineering is expected. The candidate will ideally be a Chartered Engineer and fully conversant with application routes and requirements.Experience Requirements7+ years’ experience, preferably within Biotech/pharmaceutical Manufacturing environments with a specific background in cGMP.About CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Senior Contract Manager Pandemic  

    - Maidenhead
    Senior Manager, Pandemic & Outbreak Contracts and Tenders,Internationa... Read More
    Senior Manager, Pandemic & Outbreak Contracts and Tenders,International Region(M/F/X)Type:Full-timeLocation:UKHybrid(Haywards Heath or nearEU travel hub)The Opportunity This is an international role within the Pandemic & Outbreak commercial team, requiring strong interaction with cross-functional teams, including Supply Chain, Finance, Regulatory Affairs, Medical Affairs, Legal, and Quality Team.This is a unique opportunity to play a key role in a dynamic and focused team tomaintaina leadership position in pandemic and outbreak preparedness and grow the business. This will be delivered through:Growing our existing preparedness and response partnerships anddeveloping and evolving a new business segment. ​Optimising access to the capacity available fromLaunchofa new vaccine manufacturing facilityand increased response capacity.Geo-expansion of the government customer baseThe Role: Requires ability to influence others to accept job area’s views and practices, and ability to communicate with peers and executive leadership. Lead the development and writing of complex bids or proposals in response to requests for proposals (RFPs) or tender invitations.Develop and implement winning bid strategies based on thorough analysis of customer requirements, marketintelligenceand trends.Collaborate with leaders and cross-functional teams to develop proposal strategy Manage bid timelines and deadlines to ensuretimelysubmission.Explain and negotiate with government procurement teams tooptimisedelivery of tender bids.Maintain robust tender and contract management practicesand use experience and on-the-job learning to drive continual improvement and internal efficiencies.Contribute to the Pandemic & Outbreak strategic and tactical planning and operational plan implementationSupport operational planning in the Int. Region to deliver growth plans and manage existing government customers collaboratively with cross-functional teamsYour Skills and Experience: Bachelor’s degree in sciences, business or related.Minimum of 3-5 years of experience in any of the following: bid/proposal management, business development, business-to-business account management, supply chain procurement. Ideally in pharmaceutical or healthcare industry or related sector.The ability to analyse a broad range of issues and a demonstrated ability in strategic thinking and decision-making to credibly influence peers, seniorleadershipand customer decision makers.A high levelof confidence, integrity, politicalacumenand hands-on approach to problem solving as well as a professional presence for interacting with senior management and government customers. Strong leadership and interpersonal skills to seamlessly collaborate with cross-functional teams.Excellent organisational, analytical and communications skills, with attention to detail.Excellent written and verbal communication, projectmanagementandproficiencyin Microsoft Office Suite.Ability to adapt and operate calmy between short and long-term plans and be agile to manage rapid changes.Ability to travel up to 20% (domestic or internationally).Preferred experience, not critical:Commercialisation of a vaccine in public / reimbursed market and directly with government customers (e.g.seasonal influenza, HPV, Pneumococcal, RSV)Knowledge of Pandemic influenza and/ or COVID 19 vaccine commercialisationa significant advantage.Reporting Relationships: Reports to: Senior Director, Pandemic & Outbreak, International Region HeadWhat we offerA comprehensive and inclusive benefits package, including options for life insurance and retirement plans. Twoadditionalleave days for your personal wellbeing.Learning opportunities with our CSL Academy.Find Diversity, Equality, and Inclusion at all sites and with every colleague. Come as you are.Join us and make a difference in the lives of patients with rare diseases. Apply today!About CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Enterprise Trade Compliance Manager EMEA  

    - Maidenhead
    As Enterprise Manager for EMEA within Global Trade Compliance you will... Read More
    As Enterprise Manager for EMEA within Global Trade Compliance you will be responsible for the execution and maintenance of CSL’s world-class import-export compliance program in the EMEA Region. Its focus is to ensure all CSL legal entities operating in EMEA are compliant with all applicable customs and trade regulations whilst maximizing feasible savings for the business. You will report into the CSL Enterprise Director, EMEA Trade ComplianceYou will be responsible for the day-to-day oversight of EMEA import and export transactions, ensuring compliance with local Customs and trade laws & regulations including export control laws, free trade agreements, pharmaceutical products specific partner government agencies requirements: import, export permits or registrations, duties mitigation programs, HS classification, origin, preference, and customs value determination. This position is responsible to monitor compliance readiness of CSL sites in the EMEA region.You will support EMEA CSL Customs and Trade operations in the region and manage customs brokers, and or other outsourcing providers in partnership with the logistics teams. Also partnering directly with the various CSL strategic departments, business units, and functional area leaders to implement process improvements, operational excellence, and optimize duty spend with all applicable duty mitigation programs.You will work closely with the Global Trade Compliance Program function to implement CSL Global Trade Compliance Policies, deploy regional and local procedures, monitor changes in trade regulations and inform GTC management about changes and impact to CSL, monitor the compliance readiness of the region through the management of the CSL import and export compliance risk-assessment, on site compliance reviews (audits), and support all external government audits.You will interface with CSL Business Management, CSL Global Supply chain and Logistics, Regional compliance Leadership team, customs brokers, freight forwarders, internal/external legal counsel, customers, suppliers, and CMOs. Position will also provide support to develop training materials and support the CSL Global Supply Chain with all departmental goals and objectives.Responsibilities include: -Implementing CSL Global Trade Compliance Policies, guidelines, develop and deploy regional and local procedures, monitor the compliance readiness of the region through the management of the CSL import and export compliance risk-assessment, on site compliance reviews (audits), and support all external audits.Monitoring regional key industry developments, legislative, and regulatory changes affecting CSL businesses, assess impact, and translate into processes and controls.Driving efficiency throughout the import and export processes, develop import export data, duty spend and savings metric monthly reports!Overseeing customs brokers in the region: KPIs, develop broker SOPs, adherence to contract obligations, performance, reporting of export and import data as per CSL requirements, monitoring POAs. Lead transition and implementation to new selected brokers.Leading on regional and local cross-functional teams responsible for EMEA region and customs operations.Overseeing HS and ECCN classification as well as database and GTS Master data.Responsible for origin and preference determination, including LTSD process, customs value, duties and VAT for imports and duty program utilization as per CSL Policies.Support complex customs valuations requirements for non-commercial shipments and license/permit determination/application. Responsible for best customs regimes determinationIdentifying risks and opportunities in the EMEA region and report to the Global TC teamSupporting Government audits and Customs Certifications, Internal Corporate and GTC audits. Perform post entry audits of CSL entities entries.Identifying duty VAT for cross border tax mitigation programs, analyse cost benefits and lead implementation of duty savings.Managing e GTS and Master data: denied parties Screening, Trade embargoes Blocks, and other IT GTS related upgrades and projects.Qualifications, skills, and ExperienceExperience in highly regulated, multi-location environments, cross functional experience is preferred.Experience in managing complex Customs and trade operations.Expertise in SAP GTS System and related IT projectsExperience with Customs and Export controls regulations, HS and Explanatory Notes, binding rulings, and Customs Valuation rules, as well as a thorough knowledge of entry processing, international freight industry standards and practices, and INCOTERMS.Skilled with special Customs programs (inc. FTAs, Value Reconciliation, IPR, OPR, Tariff Suspensions, bonded Warehouse etc.)Excellent skills in organization, prioritization, and negotiation; must excel under pressure.Must be self-motivated, goal oriented, and able to work independently in producing results.Proficient with: Microsoft Word, Excel, PowerPoint with ability to develop skills with other programs as required.Understands Quality systems and importance of systems, operational excellence culture and behavior to organizations.Experience in the pharmaceutical industry or other similarly regulated industry.Ability to analyze and utilize data to drive decisions and priorities.Excellent written and verbal communications skills in English.Excellent communication skills and able to influence and challenge senior leaders and peer groups.About CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • QC Analyst (Incoming and Components) 12 Month Fixed Term Contract  

    - Liverpool
    The purpose of the QC Incoming and Components Analyst role is to compl... Read More
    The purpose of the QC Incoming and Components Analyst role is to compliantly perform Primary QC inspection, Sampling of raw materials, components laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs) for all primary and secondary packaging components. QC Incoming and components analysts will be required to support release of raw materials and components for use in manufacture. QC incoming and component’s Analysts may also be required to participate in technical and validation studies in support of both departmental and site objectives.The primary responsibilities of a QC Incoming and Components Analyst is to compliantly perform component testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as defined in the EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and raw material and component sampling.It is the responsibility of QC Incoming and Components Analysts to communicate their findings as a result of testing/inspections promptly, to the QC leadership team (Team Coordinators and Manager). Specifically, it is expected that deviations (either out of specification results or compliance gaps) are highlighted to a leadership team member immediately as they are recognised.It is the responsibility of QC Incoming and Components Analysts, when assigned, to complete critical tasks such as:Instrument Maintenance and CalibrationSampling booth cleaning and monitoringInitiation of deviationsInitiation, and completion, of CAPAsCompletion of Change Control actionsUpdates and reviews of SOPsParticipation in quality risk assessmentsIt is the responsibility of QC Incoming and Components Analysts to participate in laboratory administration tasks such as:HSE risk assessment completion, review and adherenceArchiving of laboratory documentation,Ordering of materials and consumablesMaintenance of QC sample and reagent storesEnsuring a clean and safe workplace for all associatesIt is the responsibility of QC Incoming and Components Analysts to proactively maintain their own training records, and to only perform tasks that they have confirmed themselves to be compliantly trained in, in accordance with local SOPsIt is the responsibility of QC Incoming and Components Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC leadership team.Education RequirementsQC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific disciplineExperience RequirementsQC Analysts must be experienced in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standardThis position is also available to internal candidates as a secondment opportunityThe role is on a standard Days, Mon-Fri working pattern.About CSL SeqirusCSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less
  • Senior Director Global Clinical Program Lead Cardiovascular & Renal  

    - Maidenhead
    You will be accountable for the design and execution of the clinical s... Read More
    You will be accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP). You are also accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for:the timely development and execution of the Clinical Development Plan (CDP).managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management.ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.
    This position is accountable for the clinical & scientific oversight of the assigned program(s) and:ensures high quality clinical & scientific standards are met during all aspects of the programproviding clinical oversight and expertise during development of clinical studiesserves as medical monitor for assigned clinical trials or provides oversight to an assigned medical monitorserves as the Clinical Development representative on the required cross-functional Delivery Teams (DT)
    This position is a “Lead Author” or “Contributing Author” for:key study documents, including but not limited to the Clinical Development Plan (CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms (ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).the clinical sections of relevant regulatory packages (e.g. IND, NDA, annual reports) and support regulatory RFIs as needed.the development of abstracts, presentations, and manuscripts as appropriate.Main Responsibilities:1 Clinical Development Team (CDT) Leadership:Leads the integration of internal and external expert contributions to strategy and design of the assigned clinical program(s).Responsible for maintaining alignment across critical stakeholders prior to key decision making forums (e.g. Strategic and Technical Review Committee (STRC) for study outline approval.Ensures that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.Responsible for driving and documenting decision making within the CDT, facilitating issue resolution and escalation, as well as contingency planning.
    2 Clinical & Scientific Oversight:Accountable for the clinical content for all CDT deliverables to ensure safe, efficient, and timely execution of assigned clinical programs.Ensures high quality clinical and scientific standards are met throughout all aspects of the program.Serves as the clinical development representative on the required cross-functional Delivery Teams (DT) including but not limited to the Safety Management Team (SMT), the Benefit-Risk Assessment Team (BRAT), the Biomarker Expert Team (BET), and the Evidence and Access Strategy Team (EAST) for assigned programs.Develops and executes the Medical Monitoring Plan (MMP) strategy. Typically serves as the medical monitor for clinical trials during study conduct or provides oversight to assigned medical monitors.Presents results to Safety Monitoring Committee and other internal and external meetings.3 Document Authorship:Reviews the data generated during the planning and execution of a study to gather a clinical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.Leads preparations of clinical sections of relevant regulatory interaction packages including but not limited to briefing books, INDs, NDAs. BLAs, ODDs, RFIs, and routine reporting.Contributing author the publication strategy. Author or contributing author for abstracts, presentations, and manuscripts as appropriate. Qualifications and Experience Requirements:MD - Board Certified (or non-USA equivalent) in relevant field is preferred (Nephrology).Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential.5+ years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environmentAbout CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
    CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .Our Benefits Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany