OQ Manager (Operational Quality)

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Irvine Manufacturing Site. The Quality function at GSK plays a critical role in ensuring our products meet the highest standards of safety, efficacy, and compliance. As part of this team you will uphold our commitment to delivering high-quality medicines and vaccines, and healthcare products to patients and consumers around the world.

As Operational Quality (OQ) Manager you will manage Operational quality assurance activities across the site. You will coach and manage a team of Operational Quality Advisors and Quality oversight specialists to ensure products are manufactured and released to GSK and regulatory standards. You will partner with manufacturing, engineering and site leadership to keep processes and equipment within regulatory expectations. We seek a practical, curious manager who improves systems, develops people and helps the site deliver safe, high-quality product.

Responsibilities:

• Leading and developing the Operational Quality Assurance team (including succession planning and coaching).
• Overseeing material release process to ensure effective and compliant review of batch documentation, laboratory results and all other documentation associated with certification and/or release of materials.
• Ensuring quality investigations and incidents are managed appropriately and effectively.
• Managing periodic reviews (including Periodic Product Reviews – PPRs), and tracking schedules and trends.
• Acting as primary interface between Quality and site functions (to support investigations, CAPAs and change control).
• Providing quality oversight during operations, partnering with Quality oversight specialists to maintain compliant release and quiet hour activities.
• Driving continuous improvement to reduce defects and waste, supporting a culture focused on compliance and patient safety.

About You:

As this role is multi‑faceted and includes liaising with a wide variety of on‑site production and operations teams, you will be a self‑motivated person who has strong experience of working in operational quality role at a complex highly‑regulated manufacturing site. You should have people‑management experience. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

Basic Qualifications:

• Degree in a relevant scientific, technical or engineering discipline, or equivalent experience.
• Experience in pharmaceutical manufacturing quality, including operational QA.
• Solid working knowledge of Good Manufacturing Practice (GMP) and regulatory expectations for manufacturing sites.
• Practical experience with process, equipment and/or computer system validation.
• Demonstrable people leadership experience, including coaching and team development.
• Strong communication and stakeholder management skills.

Preferred Qualification:

• A fully qualified QP (Qualified Person).

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.