Operational Quality (OQ) Manager
The Quality function promotes quality and compliance throughout the product life-cycle within manufacturing and production operations at GSK Irvine Manufacturing Site. In this role you will manage Operational Quality Assurance activities, coach a team of Operational Quality Advisors and Quality oversight specialists, and partner with manufacturing, engineering and site leadership to ensure processes and equipment remain compliant with regulatory expectations.
Responsibilities
- Lead and develop the Operational Quality Assurance team including succession planning and coaching.
- Oversee material release processes to ensure effective and compliant review of batch documentation, laboratory results and all other certification or release documentation.
- Ensure quality investigations and incidents are managed appropriately and effectively.
- Manage periodic reviews (including Periodic Product Reviews – PPRs) and track schedules and trends.
- Act as the primary interface between Quality and site functions to support investigations, CAPAs and change control.
- Provide quality oversight during operations, partnering with Quality oversight specialists to maintain compliant release and quiet hour activities.
- Drive continuous improvement to reduce defects and waste, supporting a culture focused on compliance and patient safety.
About You
You are a self‑motivated leader with experience in an operational quality role at a complex highly‑regulated manufacturing site. You have people‑management experience, are resilient under pressure, possess strong people skills and a proven ability to influence and drive performance. You have a continuous‑improvement mindset, excellent written and verbal communication skills, and the ability to organise and prioritise workload.
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 Qualifications
- A fully qualified QP (Qualified Person).
GSK is an Equal Opportunity Employer.
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