Global Product Quality Strategy Lead

GSK; Barnard Castle; On-site; GBP 140,000 - 180,000; Full time

Job summary

GSK is seeking a Product Quality Strategy Director to lead end-to-end product quality strategy from pivotal readiness through launch and lifecycle management. You will ensure Quality, regulatory readiness, patient impact, and supply continuity across CMC, QA, R&D, and manufacturing in a complex enterprise matrix.

This role provides global leadership, representing Quality at PSLT and senior governance forums, and guiding risk-based recommendations, regulatory submissions, and post‑approval

Qualifications

• Bachelor’s degree required; 10+ years in pharma Quality/Technical functions
• Experience in GMP and regulatory readiness
• Experience with product lifecycle management and risk management
• Experience with regulatory submissions and inspection readiness
• Matrix leadership and governance participation experience
• Enterprise leadership aligning quality decisions with patient impact and business goals
• Demonstrated ability to influence without direct authority
• Strong understanding of GMP and global regulatory expectations

Responsibilities

• Develop, integrate, and govern end-to-end Product Quality Strategy from pivotal readiness through launch and lifecycle management
• Lead the Product Quality Team and coordinate with QA, R&D, MSAT, Manufacturing, and supply functions
• Represent Quality at PSLT, CMC, and senior governance forums with risk-based recommendations
• Provide quality leadership for pivotal filings, inspections, and post-approval readiness
• Oversee Quality elements within CMC matrix teams and milestone-readiness activities
• Drive proactive risk detection, escalation, mitigation, and governance
• Coordinate matrix oversight of QMS and lifecycle processes (CAPAs, deviations, changes, etc.)
• Improve PQS processes, standards, and organizational capability

Skills

GMP experience

Product lifecycle

Regulatory submissions

Matrix leadership

Quality risk mgmt

New product introduction

Inspection readiness

Governance participation

Education

Bachelor’s degree

Master’s degree

Job description

GSK is seeking a Product Quality Strategy Director to lead end-to-end product quality strategy from pivotal readiness through launch and lifecycle management. You will ensure Quality, regulatory readiness, patient impact, and supply continuity across CMC, QA, R&D, and manufacturing in a complex enterprise matrix.

This role provides global leadership, representing Quality at PSLT and senior governance forums, and guiding risk-based recommendations, regulatory submissions, and post‑approval