Team Lead, Therapeutic Area Quality

Overview

Quality Oversight Specialist

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. Technology is transforming manufacturing, enabling us to increase speed, quality and scale of product supply. We seek the best minds to harness smart manufacturing technologies, including robotics, digital solutions and artificial intelligence, to deliver for patients.

Position Summary:

To ensure adherence to GMP standards and procedures through independent oversight of GMP processes; to improve quality culture and continuous improvement; to maintain shift-based presence and be accountable for key quality decisions or escalations; to provide first-line support to operational areas and maintain inspection-readiness through independent checks.

• Ensure that all GMP processes and operational personnel adhere to current local or area-specific procedures, minimising risk of non-compliance and maintaining inspection readiness.
• Maintain presence across the area of responsibility and be first line of contact to support initial management of quality issues; be accountable for key quality decisions across activities such as initial impact assessments for deviations; provide guidance during GMP activities to detect potential quality issues and enable timely interventions.
• Provide Quality support for site management monitoring audits across GMP areas.
• Ensure adherence to the frequency of oversight mandated in the Quality oversight schedule.
• Check facilities are maintained in a good state per local housekeeping standards and escalate deviations with timely actions.
• Role model GPS standards by participating in tiered accountability meetings (e.g., production changeover meetings).
• Foster a Quality Starts With Me (QSWM) culture by coaching employees on procedures, doing the right thing, and explaining the impact of non-compliance on product quality and patient safety.
• Provide out-of-hours support for SLE process confirmation of non-routine or high-risk activities.

• Degree, HND/HNC or equivalent in life science, chemistry, microbiology or related subject, or substantial practical laboratory experience.
• Experience of the pharmaceutical industry with strong knowledge of QMS/GMP and related manufacturing aspects; experience in resolving cGMP issues.
• Strong influencing, communication and coaching skills; ability to contribute to department project activities.

• Familiarity with investigation tools and CAPA processes.
• Experience preparing for audits and inspections.
• Prior on-site pharmaceutical manufacturing experience.

On-site at Irvine with shift-based pattern; exact shift details to be discussed during recruitment.

We welcome applicants from all backgrounds and are committed to a supportive and inclusive environment. If you need a reasonable adjustment to the application or interview process, please tell us and we will support you.

If this role fits your skills and ambitions, apply by describing how you would lead the team, deliver quality results and make a meaningful impact.

GSK is a global biopharma company focused on uniting science, technology and talent to get ahead of disease together. We are an Equal Opportunity Employer. We encourage agile working where possible and welcome adjustments to the process if needed. If you require adjustments, contact UKRe (please note this channel is for adjustments only).

Important notices: GSK does not accept referrals from employment businesses/agencies without prior written authorization. See CMS openpayments data for transparency requirements where applicable. Details of other roles at GSK are not included in this description and may be listed separately.