OQ Team Lead; Quality Oversight

Position Summary

You will lead a small Operational Quality team that provides quality oversight across manufacturing. You will work closely with manufacturing, and supply chain colleagues to protect product quality and patient safety. This role offers visible impact and the chance to unite science, technology and talent to get ahead of disease together.

• Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System.
• Monitor quality performance using metrics and trends, escalating risk, and collaborating on corrective action plans.
• Oversee investigations of deviations, non-conformances and complaint-related issues, driving robust root cause analysis.
• Review and approve batch records, certificates and quality documentation to meet regulatory and good documentation standards.
• Support product introductions, transfers and changes, and prepare for and support audits and inspections.
• Provide oversight, support and accurate scheduling of activities for quality oversight of all GMP areas.
• Act as first line of contact to support initial management of quality issues and be accountable for key quality decision making.
• Give guidance during GMP activities to proactively detect potential quality issues through active real-time observation.
• Perform spot‑checks of activities across defined GMP areas to ensure compliance with quality standards.
• Collaborate with cross‑functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
• Review GMP documentation and records to ensure Good Documentation Practice is maintained.
• Ensure facilities meet housekeeping standards, escalating deviations and supporting remedial actions.
• Track and trend quality oversight observations and facilitate mitigation actions.
• Participate in and support site‑based audits/inspections as SME for Quality Oversight.

• Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent experience.
• 6+ years of manufacturing experience from the pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.
• Experience with quality systems such as deviations, CAPA, change control, and document control.
• Experience with data trending, statistical analysis, and root cause analysis tools.
• Experience across multiple dosage forms, packaging or device assembly activities.
• Proven experience and strong knowledge of the application of the principles of Quality Management Systems (QMS).
• Strong written and verbal communication skills for cross‑functional collaboration and supplier engagement.

• Leading or supervising a quality team in operations or supplier quality.
• Working knowledge of Good Manufacturing Practices and applicable U.S. regulatory expectations.
• Familiarity with inspection readiness and supporting regulatory inspection responses.

This role is an onsite position which requires the employee to be onsite. It is not a hybrid position.

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.