Role Purpose 职位目标
- As a Third Party Quality Manager, you will be responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provided to GSK R&D to ensure that GSK external providers of critical services (CMOs) comply with GSK data integrity and quality standards, GxP regulations and meet national health authority requirements.
- Promote and implement a Quality and Safety culture within GSK R&D.
- Provide GSK business owners and third parties with GMP expertise and regulatory compliance advisory and act as a valuable source to GSK R&D (MDS, GH, and Vx TRD) for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to R&D pipeline acceleration.

Key Accountabilities/Responsibilities
主要工作职责
- Responsible for the design, development, and deployment of Quality strategies, policies, group objectives and processes for GMP third parties supporting R&D projects, including for externalized process/product developments outsourced to CDMOs.
- Drive and support the business by implementing end-to-end quality oversight of GMP third parties in scope.
- Make the initial technical assessment of external providers, utilizing Quality Questionnaires, assess third parties (gap analysis) and drive decision-making with the remediation plan and level of audit/assessment required (quality risk management).
- Lead, negotiate, review and implement Quality Clauses/Agreements with business partners and third parties in scope and/or across R&D, to ensure compliance with current regulations, GSK quality standards associated with the activities to be carried out by the third party.
- As relevant, allow that all information/documentation (procedures – submission documentation…) be transferred to the Third Party, and act as a trainer if requested by the R&D Business Owner.
- Ensure that the Third-Party qualification is completed before the contract becomes effective and GMP operations start.
- Risk Management: Support and assist in risk areas identification, escalation, and mitigation plan development.
- Evaluate, follow up, trend, give feedback, and approve the deviations generated during activities according to the quality agreement/contract requirements.
- Ensure CAPA implementation and closure accountability, following regulatory inspections and GSK audits.
- Evaluate and follow up on change controls generated by the Third Party and escalate as needed.
- Ensure Quality Systems at Third Party site are in line with GSK expectations, through appropriate oversight and efficient analysis tools.
- Investigate major/critical deviations, issues, or technical complaints within the time frame defined. Identify and mitigate critical/major issues that could impair the performance of the activities.
- Track, analyze, and communicate metrics to ensure efforts are implemented effectively and in line with quality goals, strategy, and objectives. Identify improvement opportunities.
- Lead and perform a periodic Risk assessment regarding the Third Party, he/she is responsible for.
- Identify, assess and mitigate quality risks adequately. Develop and maintain the in-scope audit universe and propose a fit-for-purpose strategy for the yearly TP audit planning, per business needs and requirements.
- Ensure proper archiving of quality records documentation to guarantee traceability during the required retention period, by procedure, as relevant.
- Interface with R&D Procurement, Legal, Auditing Teams, and business partners to ensure internal GSK alignment on third party quality oversight, while remaining independent in his/her quality evaluation role. Interact with the Technical Development Lead/CMC Lead and PQL’s to ensure all product and process-related issues are properly addressed at the Third Party.
- Manage quality meetings (timeframe to be defined) according to a pre-defined agenda to review the quality performance, ensure highlights are captured and drive continuous quality improvement plan. Represent the Third-Party Quality team within various meetings, governances, and report points and issues within the defined timelines.
- Review and approve all the required documentation for the batch release process.
- Support audit-readiness status maintenance, preparation, conduct, and follow-up for Audit & Inspection activities, when appropriate, in direct interaction with the R&D audit team.
- Escalate, manage and support issues management. Engage with third parties on operational issues (e.g. process deviations, out-of-specifications QC results) that require an investigation by the vendor, to fully assess Product Quality impact and inform batch(es) usage decision.
- Contribute to the development, improvement & simplification of standards and processes across the R&D Third Party Quality department.
- Remain current with industry trends and changes in the regulatory and external environment through established networks – to ensure that any issues likely to impact the Third-Party network are well understood and communicated to avoid disruption to services.
- Promote partnering with peers and strong interactions with Commercial External Manufacturing teams and across R&D, and utilize its expertise to influence, simplify and provide insightful analysis to align ways of working and achieve improvement of common processes and help the R&D Quality department to optimize oversight and risk assessment of Third Parties.

Qualifications/Requirements (Education / Experience / Competencies)
申请资格 / 职位要求 (教育背景 / 工作经验 / 知识与技能)
1. Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:
1) Bachelor’s Degree & 7+ years of pharmaceutical industry.
2) Experience in at least one of the areas of Quality Assurance/Operations OR Production OR Engineering.
3) Experience with current Good Manufacturing Practices (GMPs).
4) Experience with on-site manufacturing or with external manufacturing parties.
2. Preferred Qualifications:
- If you have the following characteristics, it would be a plus:
1) Master’s degree or PhD.
2) Previous assignment experience promoting a regional or global perspective.
3) Project Management skills and leadership skills.
4) Operational Excellence experience.
5) Experience with Quality and Risk Management principles and tools.