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  • Associate Director, Clinical Scientist Oncology  

    - London
    This position will require 2 to 3 days per week onsite at a GSK office... Read More
    This position will require 2 to 3 days per week onsite at a GSK office location listed in this posting. The Associate Director, Clinical Scientist, Oncology has accountability for providing clinical input during protocol development, oversight of study conduct, and interpretation of study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient reported outcomes, and applicability of data to the targeted patient population.The Associate Director, Clinical Scientist, Oncology will lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfil regulatory and reporting requirements, and support medical governance (through the Medical Director and/or the Clinical Development Lead; and other Study Team members/stakeholders, as appropriate). The role is also responsible for designing and executing, in collaboration with the Medical Director, the clinical trial(s) assigned to the project. This role will effectively engage and influence a diverse scientific community of internal and external experts, including collaborations. Further to study/project accountability, the Clinical Scientist may manage other staff within Clinical Sciences.The Associate Director, Clinical Scientist, Oncology responsibility includes, but is not limited to:Ensure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the studyLead or contribute, as appropriate, to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisions.Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literatureIntegrate data from internal, and external academic, conference and competitor sourcesUnderstand and support creation and support of competitor landscape, medical need, regulatory strategyAppropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, etc.Implement new business processes and strategies and may also proactively identify issues and propose strategies to manage implications and risks on clinical studyEnsure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframeDrive/contribute to documents for regulatory submissionsDevelop studies in accordance with current GSK policies and proceduresAccountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDPUnderstands objectives; safety, efficacy, statistical endpoints; epidemiological and operational elements; the biology, pharmacology and toxicology; data driven phenotypes identification, biomarkers, microbiology, virologyAuthors the Clinical Study Proposal (CSP), prepares and presents the study at Protocol Review Forum (PRF), incorporates any changes suggested post-governance meetingsEnsures study protocol reflects input from internal and/or external experts/thought leadersLiaises with all functions as appropriate to ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possibleProvides input into and reviews other relevant study documents including but not limited to, the informed consent (ICF), protocol deviation management plan (PDMP), study reference manual (SRM)Contributes to all regulatory reporting requirements (e.g., DSUR, INDSRs, etc.)Ensures prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC), etc.If Internal Safety Review Committee (ISRC)/IDMC data review is required, participates in, or leads identification of internal or external ISRC/IDMC members, respectively and preparation of charter. Co-ordinates with Medical Monitor/PPL and other Study Team members and stakeholders.Identifies and ensures the review of critical safety datasets for in-stream data review in line with Medical Governance objectives (through Medical Monitor/PPL and other stakeholders, as appropriate)Participates in eCRF development and may participate in UATReviews the reporting and analysis plan (RAP) and advises on required outputsParticipates in data review ongoing through study including interim analyses, in-stream data review, etc.Responsible for ensuring the Go/No-Go criteria have been set for the studyPresents the scientific rationale and study design at Investigator Meetings and responds to scientific questions arising from sites during study conductEnsures prompt, quality communications with sites regarding protocol clarification and procedural queriesEnsures completion of medical governance (through a physician on the team) and regulatory reporting at the start to ensure overall safety of the study subjectsInterpretation of study data and scientific content of clinical study reports (CSRs) and regulatory submissionsEnsures CSR and other documents reflect input from internal and/or external experts/thought leaders as appropriateUnderstands and anticipates questions from internal and/or external stakeholders regarding data resultsWorking with the PPL and other stakeholders, clearly communicates results to internal and external stakeholders and regulatorsKnowledge of regulatory requirements to support registration; generates processes/plans and/or provides clinical input into briefing documents to support regulatory interactions/approvals and active attendance at IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, AdCom meetingsPrepares and presents data externally in the form of abstracts, posters, presentations for symposia and conferences and external journal publicationsDelivers of end-of-study reports and publication/presentation of resultsBasic Qualifications:Bachelor’s degree in Life Science or equivalent 2 or more years work experience in Pharma industry or relevant clinical trial experience1or more years Clinical trial and clinical research experience; running clinical trials in either the early or late phasesExperience working in a matrix management and large cross functional team environmentExperience generating clinical Protocols and ICFsExperience working with data management and data cleaning of clinical dataPreferred Qualifications:​Advanced degree (e.g. MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience (e.g. Study Coordinator at the site level)Oncology or immuno-oncology experience preferredAbility to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environmentGood communication skills appropriate to the target audience, promoting effective decision-making where necessaryGood knowledge of disease-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolutionBroad understanding of the pharmaceutical industry and the clinical development processGood leadership and influencing skillsExperience taking strong cross functional leadership role in clinical development; experience & understanding of clinical development from early stage through to regulatory submission and market support.Understands the study, project, and program level and can function successfully across a variety of projects.Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery.Good interpersonal skillsDemonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.Demonstrated experience leading in both matrix and line environment to deliver projects, and manage changeAbility to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.#LI-GSKPlease visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK?
    Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. Read Less
  • Clinical Operations Strategy & Planning Lead OncologyJob PurposeThe Op... Read More
    Clinical Operations Strategy & Planning Lead OncologyJob PurposeThe Operational Strategy & Planning Lead transforms clinical operations planning from a study-level to a dynamic, portfolio-wide strategy across clinical development plan (CDP), asset and indication levels.Reporting to the GCO TA Head VP, this role directly impacts operational viability, optimisation, and strategic direction by supporting data-driven planning, robust operational assessments, and early solutions identification (including Recruitment, Digital Health, Representativity, Sustainability and Patient Engagement solutions).Key Responsibilities:Collaborate with Disease Area Leaders (DALs) to capture early clinical development inputs, monitor external disease risks (e.g., new approvals, reimbursement changes, competitor trials), and align assets and indications across the portfolio, while engaging in transversal initiatives with TA Heads and DALs.Partner with Clinical Operations Asset Leads (COALs) to integrate commercial, regulatory, and representativity strategies that deliver data-driven CDPs.Coordinate with Global Monitoring and Safety Evaluation (GMASE) budget specialists to incorporate early financial assessments, ensuring key operational decisions, including country and site selections, are both operationally robust and cost-effective.Propose innovative, tech-enabled solutions, leveraging disease area insights and patient pathways to optimise recruitment, reduce complexity, and improve planning.Conduct viability assessments, coordinate peer reviews, and refine CDPs to meet regulatory, commercial, and competitive priorities while managing risks.Collaborate with COALs to identify internal risks (e.g., overlapping recruitment) and external risks (e.g., new approvals, reimbursement changes, competitor trials), generating actionable insights for ongoing trials and programs.Support the development of an integrated reporting system linking data across indications, assets, CDPs, and studies to yield actionable insights (e.g., study results' impact on CDPs, CDP-to-BLA alignments) that optimize performance and enhance visibility.Track key performance indicators to measure the function's value, using lessons learned and planned versus actual data comparisons to refine processes and improve operational baselines across teams and disease areas.Provide strategic input in GCO TA leadership team discussions by standardizing operational viability assessment and planning support frameworks across disease areas while ensuring necessary tailoring.Lead continuous improvement initiatives by piloting digital tools, AI/ML solutions, and predictive analytics to enhance planning accuracy, efficiency, and costs and resource management.Basic Qualifications: • Bachelor’s degree in a relevant field (e.g., Life Sciences, Clinical Research, Business, or related expertise).• 7+ years of relevant industry experience, with proven expertise in Oncology.• Demonstrated leadership in clinical development operations, CDP planning, or study feasibility roles within a global, multinational environment, such as at a CRO, pharmaceutical company, or similar organization, and the ability to thrive in ambiguous, uncertain, dynamic environments, adapting to rapidly evolving internal priorities and external insights.• Proven experience in strategic problem-solving and an in-depth understanding of the drug development process as well as relevant industry guidelines (FDA, GCP, ICH).• Proven experience managing portfolio-level planning across multiple disease areas and delivering strategic insights for consideration during internal governance board presentations to GSK senior leadership.• Project management experience in a complex, matrix organization.• Experience in analysing data from divergent sources to produce actionable, strategic recommendations.• Experience in driving process improvements and managing handover processes between strategic planning and detailed operational execution.Preferred Qualifications: • Master’s or PhD degree in a relevant field.• Knowledge of Agile methodologies.• Experience utilizing clinical trial recruitment modeling tools and industry data sources (e.g., CiteLine, DQS, TriNetX).• Experience spanning multiple disease areas.• Expertise in data analysis and interpretation, visualization, and digital analytics.• High proficiency with Microsoft Office tools.• Strong influencing, negotiation, and communication skills.We Offer:• An opportunity to redefine clinical operational planning by transitioning from traditional study-level iterations to a streamlined, strategic asset, indication and CDP-level approach.• A pivotal Director-level role with portfolio-level oversight, enabling you to influence strategic decisions at senior leadership levels.• A collaborative and innovative environment where your leadership and strategic vision will drive continuous improvements in clinical operations planning.Clinical Operations Strategy & Planning Lead OncologyJob PurposeThe Operational Strategy & Planning Lead transforms clinical operations planning from a study-level to a dynamic, portfolio-wide strategy across clinical development plan (CDP), asset and indication levels.Reporting to the GCO TA Head VP, this role directly impacts operational viability, optimisation, and strategic direction by supporting data-driven planning, robust operational assessments, and early solutions identification (including Recruitment, Digital Health, Representativity, Sustainability and Patient Engagement solutions).Key Responsibilities:Collaborate with Disease Area Leaders (DALs) to capture early clinical development inputs, monitor external disease risks (e.g., new approvals, reimbursement changes, competitor trials), and align assets and indications across the portfolio, while engaging in transversal initiatives with TA Heads and DALs.Partner with Clinical Operations Asset Leads (COALs) to integrate commercial, regulatory, and representativity strategies that deliver data-driven CDPs.Coordinate with Global Monitoring and Safety Evaluation (GMASE) budget specialists to incorporate early financial assessments, ensuring key operational decisions, including country and site selections, are both operationally robust and cost-effective.Propose innovative, tech-enabled solutions, leveraging disease area insights and patient pathways to optimise recruitment, reduce complexity, and improve planning.Conduct viability assessments, coordinate peer reviews, and refine CDPs to meet regulatory, commercial, and competitive priorities while managing risks.Collaborate with COALs to identify internal risks (e.g., overlapping recruitment) and external risks (e.g., new approvals, reimbursement changes, competitor trials), generating actionable insights for ongoing trials and programs.Support the development of an integrated reporting system linking data across indications, assets, CDPs, and studies to yield actionable insights (e.g., study results' impact on CDPs, CDP-to-BLA alignments) that optimize performance and enhance visibility.Track key performance indicators to measure the function's value, using lessons learned and planned versus actual data comparisons to refine processes and improve operational baselines across teams and disease areas.Provide strategic input in GCO TA leadership team discussions by standardizing operational viability assessment and planning support frameworks across disease areas while ensuring necessary tailoring.Lead continuous improvement initiatives by piloting digital tools, AI/ML solutions, and predictive analytics to enhance planning accuracy, efficiency, and costs and resource management.Basic Qualifications: • Bachelor’s degree in a relevant field (e.g., Life Sciences, Clinical Research, Business, or related expertise).• 7+ years of relevant industry experience, with proven expertise in Oncology.• Demonstrated leadership in clinical development operations, CDP planning, or study feasibility roles within a global, multinational environment, such as at a CRO, pharmaceutical company, or similar organization, and the ability to thrive in ambiguous, uncertain, dynamic environments, adapting to rapidly evolving internal priorities and external insights.• Proven experience in strategic problem-solving and an in-depth understanding of the drug development process as well as relevant industry guidelines (FDA, GCP, ICH).• Proven experience managing portfolio-level planning across multiple disease areas and delivering strategic insights for consideration during internal governance board presentations to GSK senior leadership.• Project management experience in a complex, matrix organization.• Experience in analysing data from divergent sources to produce actionable, strategic recommendations.• Experience in driving process improvements and managing handover processes between strategic planning and detailed operational execution.Preferred Qualifications: • Master’s or PhD degree in a relevant field.• Knowledge of Agile methodologies.• Experience utilizing clinical trial recruitment modeling tools and industry data sources (e.g., CiteLine, DQS, TriNetX).• Experience spanning multiple disease areas.• Expertise in data analysis and interpretation, visualization, and digital analytics.• High proficiency with Microsoft Office tools.• Strong influencing, negotiation, and communication skills.We Offer:• An opportunity to redefine clinical operational planning by transitioning from traditional study-level iterations to a streamlined, strategic asset, indication and CDP-level approach.• A pivotal Director-level role with portfolio-level oversight, enabling you to influence strategic decisions at senior leadership levels.• A collaborative and innovative environment where your leadership and strategic vision will drive continuous improvements in clinical operations planning.Li-GSK*Hybrid*Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK?
    Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. Read Less
  • Director, Real-World Biostatistics  

    - Stevenage
    The Director, Real-World Biostatistics (RWB) is a key role focused on... Read More
    The Director, Real-World Biostatistics (RWB) is a key role focused on advancing strategy and methodology in the entire course of drug/vaccine development using real-world data (RWD) within the enterprise. This position requires deep biostatistical expertise, strategic insight, and supporting methodological innovation to enhance the development and commercialization of pharmaceutical products, primarily in the respiratory, immunology and inflammation research unit (RIIRU).The Director will design and analyze RWD studies and other observational studies using cutting-edge biostatistical methodologies associated with causal inference and comparative effectiveness, clinical outcomes assessment, longitudinal and predictive modelling, and target trial emulation, while also mentoring staff assigned to these projects. :Biostatistical and Methodologic Support:·Lead and oversee the execution of real-world studies, ensuring methodological rigor, quality control, and regulatory adherence.·Create and refine statistical analysis plans, conduct complex statistical analyses, and convey findings to internal and external stakeholders.·Apply fit for purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.Therapy Area Knowledge:·Develop in-depth knowledge on assigned assets and act as senior-level RWB consultant on matrix teamsProject Management and Staff Mentorship:·Mentor junior staff, guiding and developing their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing, continuous learning, and an innovative and collaborative environment.·Lead statistical efforts for assigned projects, manage timelines, resources, quality control, and coordinate across departments (e.g. epidemiology, health economics and outcomes research, clinical).Communication and Strategic Initiatives:·Engage in strategic communication within the organization and with external audiences presenting statistical analyses and insights clearly and effectively at conferences, in publications, and during key stakeholder meetings, reinforcing the value of biostatistical contributions.Methodological Development and Innovation:·Stay informed on industry trends, incorporate emerging biostatistical methods to enhance study designs and analytics, and participate in methodological research for the development of analytical techniques.Regulatory Support and Compliance:·Provide biostatistical expertise on RWD during regulatory submissions, meeting preparations, and addressing queries to ensure alignment with regulatory standards while offering statistical guidance for organizational decision-making processes.·Stay informed with guidance documents from regulators to industry on the use of RWD for regulatory decision-making.Basic Qualifications:·Ph.D. in Statistics, Data Science, Epidemiology or related disciplines with 8+ years (or Masters plus 10+ years) of working within the pharmaceutical/biotech industry (preferably in real-world evidence, epidemiology, or health outcomes functional areas).·Experience in working with drug development processes and strategies, utilizing innovative statistical skills to meet project and/or business objectives.·Experience leading pharmacoepidemiology and/or health outcomes analytics using RWD (e.g. electronic health record; insurance claims; registries) and applying observational study design and biostatistical principles to clinical/epidemiological research.·Expereince in programming languages (e.g. R, Python) and applied experience with observational data.·Experience in working according to regulatory requirements pertaining to RWD and clinical trials.·Experience in managing projects, delivering results in matrixed environments.·Experience in methodological research with contributions to publications in real-world data analytics.Preferred Qualifications:·Experience in causal inference methodology such as propensity score based approaches, doubly-robust estimations including target maximum likelihood estimation (TMLE), principal stratification/instrumental variable approaches, methods for time-varying exposures.·Experience in time-to-event analysis in the setting of non-randomized studies.·Experience in machine learning.#LI-GSKPlease visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK?
    Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. Read Less
  • Quality Inspection Readiness Director  

    - Ware
    We manufacture and supply reliable, high-quality medicines and vaccine... Read More
    We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
    Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible.Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
    We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

    Are you ready to make a meaningful impact in ensuring regulatory compliance and inspection readiness across a global organization? As a Quality Inspection Readiness Director, you will play a key role in supporting sites to meet regulatory standards and maintain inspection readiness every day. You will collaborate with cross-functional teams, provide expert guidance, and drive continuous improvement in compliance processes. This is an opportunity to grow your career while contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.Support GSK sites/related functions that are inspected by key regulators (FDA, MHRA, EMA (outside of Europe), HPRA and China) to be inspection ready through Inspection Readiness Pre, During and Post Inspection activities (including PAI inspection readiness)Pre-Inspection - Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approachPreparation of clear and objective assessment reports that ensure that senior management is communicated any inspection readiness risks and that appropriate corrective action plans are implemented which are associated with those risksDuring Inspection – Provide appropriate support for all key Regulatory Inspections (e.g. SME coaching, Control Room and Inspection Room Support)Post Inspection – Review the regulatory response as part of the central review team process, perform Global Assessments and participate in After Action Reviews. If necessary, initiate Muti-Site Commitment actions if there is a wider GSK impact by the regulatory responseServe as a business partner to enhance GSK’s risk management capabilities and actively identify and share good practices and improvement opportunities in the appropriate formatSupport site capability building through training and coaching of site SMEs in preparation for GMP regulatory InspectionsReview and check CAPA for key regulatory inspections and engagements before the next site inspection by a key regulator to ensure they have been closed out effectively.Attend internal forums (as required) as GMP/GDP expert, providing recommendations to provide recommendations for continued compliance with regulations, in support of the simplification and advancement of the use of new technology in the current processesProvide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and proceduresIn addition:Be the point of contact with sites being assessed for inspection readinessPropose updates to Global QMS Documents and/or local site SOPs based upon identified compliance gapsAssist in training and coaching of guest assessorsExpand knowledge through proactive knowledge sharing and collaborationPromote excellence and continuous improvement associated with inspection readiness, best practice and processesSupport site capability building through training and coaching of site SMEs in preparation for InspectionsWork with the QMS team on QMS policies & global processes associated with Inspection Readiness teamParticipation in IR CoP/Compliance ForumShare learning from significant Regulatory Inspections across GSC as necessaryDevelop and maintain tools to support inspection readiness processEnsure suitable metrics (KPI’s) are in place and are available to support decision-making within GSK
    Basic Qualifications
    Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
    Preferred Qualifications
    Good knowledge of world-wide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterileProficiency & experience in identifying Regulatory Inspection RisksDemonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissionsBroad based familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturingGood knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP complianceKnowledge of risk management principles and applicationUnderstanding and experience of corporate governance processesSerious Incident management with demonstrated ability to resolve quality issuesDemonstrated improvement in processes associated with being inspection ready
    This role is hybrid, but requires the candidate to be close to a GSK site. This role will require travel up to 50%.

    Join us in this impactful role and help ensure GSK’s commitment to quality and compliance. Apply today to be part of a team that’s making a difference in global health!The US annual base salary for new hires in this position ranges from $151,800 to $253,000 The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Please visit to learn more about the comprehensive benefits program GSK offers US employees. Why GSK?
    Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. Read Less

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