Global Product Quality Strategy Lead

Gsk

Hertford Heath

On-site

GBP 120,000 - 180,000

Full time

5 days ago
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Job summary

GSK in the United Kingdom seeks a Product Quality Strategy Director to set, integrate, and govern end-to-end quality strategy for pivotal assets from development through launch. You will lead a global Quality voice across CMC, Regulatory, R&D, MSAT, Manufacturing, Site Quality, and partnering functions to ensure patient safety and regulatory readiness.

This role demands senior matrix leadership, strategic risk management, and oversight of quality controls, lifecycle changes, and

Qualifications

  • Minimum 10 years of pharmaceutical-industry experience across Quality and/or Technical functions.
  • Experience in GMP and product lifecycle management.
  • Experience with product quality risk management and new product introduction.
  • Experience with regulatory submissions and inspection readiness.
  • Matrix leadership experience.

Responsibilities

  • Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management.
  • Lead the Product Quality Team and influence multiple functions to align priorities and readiness plans.
  • Represent Quality as the One Quality Voice at governance forums and provide objective risk-based recommendations.
  • Provide Quality leadership for pivotal, filing, launch, inspection, and post-approval readiness in regulatory submissions and controls.
  • Drive proactive product quality risk detection, governance, escalation, mitigation, and acceptance with clear ownership.
  • Coordinate matrix oversight of QMS and lifecycle processes including changes, deviations, CAPAs, complaints, and regulatory submissions.

Skills

GMP
Product lifecycle management
Product quality risk management
Regulatory submissions
Inspection readiness
Matrix leadership

Job description

GSK in the United Kingdom seeks a Product Quality Strategy Director to set, integrate, and govern end-to-end quality strategy for pivotal assets from development through launch. You will lead a global Quality voice across CMC, Regulatory, R&D, MSAT, Manufacturing, Site Quality, and partnering functions to ensure patient safety and regulatory readiness.

This role demands senior matrix leadership, strategic risk management, and oversight of quality controls, lifecycle changes, and

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