OQ Team Lead (Quality Oversight)

GSK•Zebulon, NC

6d•Onsite

About The Position

The OQ Team Lead will lead a small Operational Quality team providing quality oversight across manufacturing. The role works closely with manufacturing and supply chain colleagues to protect product quality and patient safety, monitor quality performance, manage risks, and drive measurable improvement. The position includes visible leadership and decision-making responsibilities across GMP areas, along with coaching teams and supporting product introductions, transfers, changes, audits, and inspections. This is an onsite role and is not hybrid.

Requirements

Bachelor’s degree in science, pharmacy, engineering, or a related discipline, or equivalent pharmaceutical industry experience.
At least 6 years of manufacturing experience in the pharmaceutical industry, biologics manufacturing, distribution, supplier quality, or quality operations.
Experience with quality systems, including 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 applying Quality Management System (QMS) principles.
Strong written and verbal communication skills for cross-functional collaboration and supplier engagement.

Nice To Haves

Experience 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.

Responsibilities

Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System.
Monitor quality performance using metrics and trends, escalate risks, and collaborate 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; prepare for and support audits and inspections; and coach internal teams and external partners on inspection readiness.
Provide oversight, support, and accurate scheduling for the quality team responsible for oversight of GMP areas, ensuring requirements are met and defined schedules are followed.
Maintain a presence across areas of responsibility, provide first-line support for initial management of quality issues, and make key quality decisions, including initial deviation impact assessments.
Guide GMP activities and use real-time observation to detect potential quality issues and enable timely interventions.
Spot-check activities across GMP areas, including production, testing, QC, warehouse, facilities, and utilities, to ensure compliance with quality standards.
Collaborate with cross-functional teams to resolve quality issues, implement corrective and preventive actions (CAPAs), and support continuous improvement.
Review GMP documentation and records to ensure Good Documentation Practice and ALCOA++ data-integrity, audit, and traceability principles are followed.
Check that facilities meet local housekeeping standards, escalate deviations, and support timely remedial actions.
Track and trend quality oversight observations, facilitate mitigation actions, and regularly update and maintain the quality oversight risk assessment.
Participate in and support site-based audits and inspections as a Quality Oversight subject-matter expert.