Third Party Quality Oversight Manager

The Third Party Quality Oversight Manager is accountable for providing independent, end‑to‑end quality oversight and assurance of the external third‑party base, including material suppliers, contract manufacturers, and logistics service providers.

• Provide independent, end‑to‑end quality oversight and assurance of external third parties, ensuring compliance with applicable GMP/GDP regulations, regulatory authority expectations, and internal quality standards.
• Establish, maintain, and continuously enhance third party quality governance frameworks, ensuring a consistent, standardised, and risk‑based approach to oversight across the external network.
• Act as the independent Quality authority for third party compliance decisions, providing objective, evidence‑based judgments free from commercial, supply, or operational influence.
• Define and maintain clear governance boundaries between site‑owned supplier management activities and central Quality oversight, ensuring effective assurance while avoiding duplication, ambiguity, or gaps in accountability.

• Develop and execute risk‑based GMP/GDP audit strategies for third parties, including routine, qualification, re‑qualification, and for‑cause audits, aligned with regulatory risk, business criticality, and performance history.
• Lead and manage the end‑to‑end audit lifecycle, including audit planning, execution, reporting, follow‑up, and closure, ensuring consistency, robustness, and inspection readiness.
• Own and govern third party qualification and re‑qualification outcomes, including approval recommendations, conditional approvals, remediation requirements, and escalation of high‑risk or non‑compliant partners.
• Ensure audit execution and documentation are inspection‑ready, evidence‑based, and defensible, aligned with regulatory expectations and internal Quality governance standards.
• Act as a Lead Auditor and contribute to audit capability building, mentoring, and continuous improvement of audit practices where required.

• Design, implement, and continuously refine risk‑based oversight models, integrating audit outcomes, quality performance indicators, deviation and CAPA trends, complaints, recalls, and relevant external intelligence.
• Proactively identify, assess, and escalate systemic quality, compliance, and supply risks arising from third party activities, ensuring timely visibility and informed decision‑making.
• Provide clear, concise, and data‑driven reporting on third party quality performance, risk trends, and audit outcomes to Quality Governance forums and senior leadership.
• Support enterprise‑level third party risk management, enabling transparent, evidence‑based decisions regarding supplier selection, continuation, remediation, or disengagement.

• Provide independent Quality oversight of CAPA management arising from third party audits, inspections, and quality issues, including assessment, approval, prioritisation, and effectiveness verification.
• Ensure CAPAs are root‑cause driven, proportionate to risk, sustainable, and measurable, with timely implementation and demonstrable effectiveness.
• Drive continuous improvement of third party oversight processes, audit methodologies, governance standards, and supporting tools to strengthen compliance and operational robustness.

• Partner with Procurement, Supply Chain, Site Quality, Operations, and other key stakeholders to establish and maintain robust, transparent, and effective external quality assurance models.
• Support the definition and reinforcement of clear roles, responsibilities, and accountability models across central and site‑level teams for third party quality management.
• Act as a trusted Quality partner, providing expert guidance, constructive challenge, and influence to support compliant, risk‑based business decisions across the external supply network.

• Bachelor’s degree in a scientific, quality, or related technical discipline, or equivalent professional experience.
• 5–8 years’ experience in…