Product Quality Strategy Leader at GSK in King of Prussia, PA

Job description

The Product Quality Strategy Director is accountable for setting, integrating, and governing end-to-end Product Quality Strategy for business-critical assets from Commit to Pivotal Readiness through initial commercial launch in major markets and critical lifecycle change activities. The role serves as the independent Quality representative and One Quality Voice across CMC, Quality, R&D, MSAT, Manufacturing, Regulatory Affairs, Site Quality, QC, supply functions, and strategic partners. Through enterprise matrix leadership, the role ensures product quality, patient impact, regulatory and inspection readiness, supply continuity, and product quality risk management are embedded in development, registration, launch, commercialization, and lifecycle decisions. Oversight continues where post-approval supply-chain changes, acquisitions, alliance products, or strategically critical portfolios require sustained senior quality leadership outside manufacturing-site operational ownership. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management, ensuring Quality, Technical Development, Product Quality Risk, Compliance, Regulatory, patient, and supply considerations are embedded in asset strategy and governance decisions. Lead the Product Quality Team and influence GSC Technical, GSC Product Strategy, GRA CMC, R&D CMC, Quality, R&D, MSAT, Manufacturing, Site Quality, QC, supply functions, and strategic partners to align priorities, decisions, readiness plans, and accountable delivery. Represent Quality as the One Quality Voice at PSLT, CMC, product, and other senior governance forums, providing objective risk-based recommendations, resolving quality-position differences, and escalating unresolved issues through appropriate governance routes. Provide Quality leadership for pivotal, filing, launch, inspection, and post-approval readiness, including strategic input to control strategy, comparability strategy, regulatory submissions, health-authority responses, PAI preparation, and critical quality controls, as applicable. Be accountable for Product Quality elements within CMC matrix teams and for Quality review, approval, and execution oversight of Product Quality deliverables and milestone-readiness activities, as required. Drive proactive product quality risk detection, assessment, governance, escalation, mitigation, and acceptance, ensuring clear accountable owners, effective action plans, documented rationale, and timely senior-governance visibility. Coordinate matrix oversight of relevant QMS and lifecycle processes for assigned assets, including changes, deviations, CAPAs, complaints, product quality reviews, validation, post-approval changes, dossiers, regulatory submissions, and associated controls. Drive end-to-end Product Quality for commercial Vaccines or Medicines as a competitive advantage through proactive product, process, analytical, digital, and knowledge-management improvements that strengthen patient outcomes, compliance, supply continuity, and business performance. Serve as global subject matter expert for new product introduction and product quality lifecycle change management and, as applicable, Major Change Control Reviewer, PIRC member, and Quality point of contact for Alliance and Strategic Partners. Improve Product Quality Strategy processes, standards, governance frameworks, and organizational capability through lessons learned, coaching, knowledge sharing, reusable tools, and continuous improvement. Translate complex technical, quality, compliance, regulatory, patient, and supply risks into clear business recommendations and governance decisions. Monitor product quality signals, complaint trends, deviations, CAPAs, product quality reviews, stability, and lifecycle information to