OQ Team Lead (Quality Oversight)

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines 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 not just core to our operations; it’s 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.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

• Lead and coach the Operational Quality team to deliver consistent oversight of the Quality Management System. Monitor quality performance using metrics and trends, escalate 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 have been met, and the defined schedule is followed. 

• Maintain presence across areas of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as 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 a spot-check 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/preventive actions (CAPAs) and support continuous improvement efforts. 

• Review GMP documentation and records ensuring Good Documentation Practice (GDP) is being maintained following ALCOA++ principles for data integrity, audit and traceability 

• Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated and support timely implementation of remedial actions 

• Track and trend quality oversight observations on collected data and facilitate mitigation actions and regularly update and maintain the quality oversight risk assessment 

• Participates in and supports site-based audits/inspections as SME for Quality Oversight.