About the responsibilities
- Responsible for the design, development, and deployment of Quality strategies for GMP/GDP third parties supporting Vx TRD for Vaccine 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 (this includes, but not only: make the initial technical assessment of external providers, assess third parties and quality risk management; lead, negotiate, review and implement Quality Clauses/Agreements with business partners and third parties in scope and/or across R&D, including GSK Pharma R&D for vendors in common, to ensure compliance with current regulations, GSK quality standards associated with the activities to be carried out by the third party; 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).

• Interface with R&D Procurement, Legal, Auditing Teams, and business partners including GSK Corporate and Pharma R&D to ensure internal GSK alignement on third party quality oversight, while remaining independent in his/her quality evaluation role. Interact with the Technical Development Lead and CMCQ to ensure all product and process-related issues are properly addressed at the Third Party.

• Review and approve all the required documentation for the batch release process and contribute to the GMP Third Parties release certification (batch review delegation to TP) and re-assessment process; support audit-readiness status maintenance, preparation, conduct, and follow-up for Audit & Inspection activities, when appropriate, in direct interaction with the Vx Quality for 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 Q4R&D Third Party department, specifically within TPQ, and in the context of the R&D QMS implementation.

• 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 between GSK Vaccines R&D and Pharma 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 Q4R&D department to optimize oversight and risk assessment of Third Parties.