Operational Quality Advisor

Business Introduction We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations;

it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

The Operational Quality Advisor plays a crucial role in maintaining the quality and compliance of various materials and processes within the GSK Irvine site. You will be responsible for the release of raw materials, starting materials, intermediates, drug substance and blends. This role is critical for ensuring that the products manufactured by the organisation are safe, effective, and of high quality, ultimately protecting patient safety and maintaining the overall quality assurance.

• Participate in assessment of non-conformances with cGMP, deviations and customer complaints investigations and ensure that appropriate CAPA has been identified and verification of CAPA effectiveness and deviation trending is carried out.
• Approve master batch sheets, SOPs, specifications and methods to ensure compliance with GMP and licence registrations.
• Participate in Operational Quality approval of changes in a compliant manner to ensure that proposed changes are planned and evaluated.
• Plan, conduct and document internal quality audits to ensure GMP compliance.
• Evaluate site Right First time performance and drive improvements in the RFT figures.
• Complete product stability protocols and periodically evaluate the stability profiles to ensure the quality of the products manufactured.
• Provide support and advice both informally and through quality councils to Operations to ensure continued business compliance.
• Review of batch documentation, test results and all other documentation associated with certification (for EU) and release of Finished Product.
• Provide Batch certification for release.
• Review and approve of Technical Terms of Supply (TTS) and associated quality agreements to include review and approval of changes and assessment of deviations and trends.
• Approve distribution risk assessments to assure compliance with cGMP.

• Degree or HNC/HND or equivalent with relevant GMP experience.
• Strong organizational and decision-making skills, excellent communication skills, and ability to manage change.
• Experience with in the Pharmaceutical Industry including an in-depth knowledge of cGMP/GQLP and Quality issues.

• Experience of working in the GMP operational environment.
• Experience in systems utilized for role, such as SAP / M-ERP, VQMS.

13th February 2026 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

If this role feels like your next step, please apply and briefly tell us how your experience meets the responsibilities and qualifications. If you need any reasonable adjustments during the recruitment process, please tell us. We look forward to hearing from you.

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…