External Quality Lead

Business Introduction
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

This position is responsible is for the Quality oversight of assigned Contract Manufacturing Organisations (CMOs) in an External Manufacturing specific Region to ensure MAH’s product quality, compliance and reputation is protected.

This role will be accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned CMO(s) and with internal stakeholders. These include Procurement, Technical, Supplier Relationship, Regulatory, Business Development, Production, Site Management and other related GSK functions.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead Quality Agreement negotiations with CMOs and implement Quality Systems performance management with appropriate KPIs based on contractual parameters.

• Ensure regulatory compliance is managed through flow of regulatory information to and from the releasing Sites as governed by Quality Agreements.

• Monitor the quality performance of the CMO driving remedial action where necessary. Monitor and assess CMO’s key performance indicators, such as complaints and deviations as a mechanism to propose continuous improvement initiatives. Apply appropriate Risk management tools with each CMO, escalating and tracking significant risks requiring resolution, including Risk Management System (RMS) reporting to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC) or other corporate governance processes, as required, to drive routine GEMBA with purpose as defined in the GEMBA Plan in order to assess the Supplier on the shop floor.

• Partner with GSK functions, such as EM Procurement, Quality, Technical and Supply (PQTS+) to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product. 

• Partner with the CMO(s) to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance. Provide specific GMP training for contractors, where deemed necessary. Review and disposition batch records when responsibility falls within EQ.

• Drive periodic review of Quality Systems at the CMO(s), to complement audit processes. Where required, support the CMO by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions.

• Evaluate effectiveness of the CMO’s Quality Unit and systems and influence CMO(s) promoting robust systems operating under self-sufficient organizations. Escalate serious cGMP/Regulatory compliance issues following internal procedures. Support efforts that positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly distributed for incorporation in local action plans.

• Actively participate on the External Manufacturing Quality Review Meetings,  identifying Quality related issues and continuous improvement opportunities, with proposals to address these.

• Review and respond to CMO(s) regulatory inspections on matters that involve activities related to GSK products.  Assess impact of inspections and CMO responses to Regulatory observations prior to submission to the associated agency.

• Work with External Suppliers to establish effective CAPAs, in response to GSK audit observations and ensure the CMO(s) manage these to acceptable closure. Ensure timely communication of Quality Alert issues. Co-ordinate and track any continuous improvement / Quality Plans deemed necessary. Support or lead internal audit processes where required.

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