Operational Quality Director

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.

Key Responsibilities

• 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.
• 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.

Scope of Accountability

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

Basic Qualifications

• 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 cGMP’s/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 analyse complex data, drive continuous improvement, and lead teams under pressure while maintaining a culture of quality and compliance.
• Strong business and operational knowledge and acumen.

Preferred Qualifications

• Advanced degree (Master’s or PhD) in a relevant Life Science or Engineering discipline.
• Experience operating in large, matrixed global organisations.
• Demonstrated ability to lead change, elevate quality culture, and drive digital and operational transformation.

Closing Date for Applications 26 May 2026 (EOD)

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.