Senior Manager, Third-Party Quality

Are you energized by a highly impactful quality role that drives process improvement and broad stakeholder engagement?  If so, this Senior Manager, Third-Party Quality opening could be an ideal opportunity to explore.

As a Senior Manager, Third-Party Quality, 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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• 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 &