Operational Quality Director

Overview

Site Name: UK - Hertfordshire - Ware
Posted Date:
Feb 2 2026

GSK is seeking a highly experienced and quality‑driven Director, Operational Quality to ensure uncompromising compliance across manufacturing and Quality Operations. In this critical leadership role, you will oversee the end‑to‑end quality oversight of production activities, ensuring that all products are manufactured, tested, and released in full alignment with GSK standards, cGMP expectations, applicable regulatory requirements, business commitments, and strategy.

You will lead the Operational Quality function — including batch documentation governance, real‑time shop‑floor quality oversight, and the Qualified Person (QP) team — ensuring products consistently meet license commitments and quality expectations. You will drive the effectiveness of key Quality Systems such as deviation and incident management, change control, complaints, and CAPA, while championing consistency, continuous improvement, and inspection readiness across the site.

As part of the site Quality Leadership Team (QLT), you will play a central role in strengthening quality culture and ensuring our site delivers safe, compliant, high‑quality medicines to patients.

In this influential role, you will provide leadership across Operational Quality and site Quality systems, ensuring consistent, objective, and high‑integrity decision making. Specific responsibilities include:

• Ensuring that products released by the site comply with regulatory filings, cGMP requirements, and internal GSK quality standards, through strong governance and oversight of Operational Quality teams.
• Leading, managing, and assuring the accuracy and completeness of batch documentation, laboratory data, and all supporting information required for certification and product release.
• Overseeing the management of investigations — including deviations, complaints, returned goods, unexpected events, and product failures — ensuring robust root‑cause analysis, impact assessments, and effectiveness of CAPA.
• Ensuring real‑time quality oversight of manufacturing operations, facilities, and equipment, with a strong focus on data integrity, adherence to procedures, and timely escalation of Quality or Safety risks.
• Governing the change control process to ensure that changes impacting product, process, method, materials, facility, or equipment are assessed, justified, and implemented compliantly.
• Ensuring that Quality systems, procedures, and policies across the site remain current, compliant, and aligned with GSK QMS and regulatory requirements.
• Supporting successful regulatory and internal inspections, including hosting, preparation, and oversight of responses, CAPA development, and sustainable embedding of improvements.
• Leading, coaching, and developing a high‑performing Operational Quality team; driving performance, engagement, accountability, and continuous improvement (including RFT and documentation cycle times).
• Supporting operational and budget planning for the OQ function, contributing to site strategy and annual targets.
• Applying GPS tools (e.g., GEMBA, Process Confirmation, 5S) to identify improvement opportunities and strengthen deviation prevention, compliance, and operational flow.

• Direct Reports: 6–10
• Indirect Reports:
  Up to 40

• Bachelor’s degree in Life Sciences (e.g., Biotechnology, Biology, Pharmaceutical Sciences, Physical Sciences).
• Demonstrated regulated industry experience (pharmaceutical/biotech) combined with experience in leadership roles.
• Strong working knowledge of cGMPs/FDA and other regulatory requirements e.g ICH Guidelines 8, 9, 10, 11 including RoW standards, WHO, Eudralex, etc.
• Demonstrated experience leading Quality Assurance teams, managing inspections, and navigating complex quality and operational decision making.
• Proven expertise in Pharmaceutical Quality Systems, batch release governance, deviation and change control management, and technical investigations.
• Strong communication skills and the ability to influence and collaborate across multiple disciplines and seniority levels in a highly regulated environment.
• Ability to…