435006

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

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.

Scope of Accountability

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

Basic Qualifications

We are looking for professionals with these required skills and experiences to achieve our goals:

• 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 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

If you have the following, it would be a plus:

• 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)

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' for your online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you provide in your cover letter and CV will be used to assess your application.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team...