OQ Team Lead; Quality Oversight

Business Introduction

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is vital to bringing our innovations to patients as quickly, efficiently and effectively as possible.

Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

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, career growth 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, elevate risk, and collaborate on corrective action plans.
• Oversee investigations of deviations, non‑conformances and complaint‑related issues and drive 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 of activities to the quality team responsible for quality oversight of all GMP areas ensuring all requirements are met and the defined schedule is followed.
• Maintain presence across areas of responsibility and act as first line of contact to support initial management of quality issues, including the initial impact assessment for deviations.
• Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real time, allowing for timely interventions to prevent deviations and defects.
• Perform spot‑checks of activities across defined GMP areas to ensure compliance with quality standards that include production, testing, QC, warehouse, facilities and utilities.
• Collaborate with cross‑functional teams to resolve quality issues, implement corrective and preventive actions (CAPAs) and support continuous improvement efforts.
• Review GMP documentation and records ensuring Good Documentation Practice (GDP) is maintained following ALCOA++ principles for data integrity, audit and traceability.
• Check that facilities are maintained in a good state in line with local housekeeping standards and that any deviations from the standards are escalated with timely remedial action.
• Track and trend quality oversight observations on collected data and facilitate mitigation actions, regularly updating and maintaining the quality oversight risk assessment.
• Participate in and support site‑based audits and 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…