Own and lead global compliance monitoring programs for all GxP third parties, ensuring timely qualification, requalification, or disqualification.
Design and manage a global, risk-based GxP audit program covering GMP, GDP, GCP, GLP, and GVP audits, both remote and on-site.
Oversee third-party audits, ensuring findings are risk assessed, reported, and closed with appropriate CAPAs; follow up on CAPA completion.
Maintain and assess approved supplier and vendor lists, including criticality ratings and compliance status.
Ensure all qualification and requalification activities align with EU, UK, and FDA GxP expectations and internal SOPs.
Monitor ongoing third-party performance using audits, KPIs, deviations, complaints, and quality metrics.
Lead risk-based internal audit programs and delegate audits to appropriately qualified personnel.
Support development, review, and management of Quality/Technical Agreements (QTAs) and Service Level Agreements (SLAs) with Legal and Operational leads.
Serve as the quality lead for new third-party onboarding, due diligence, and qualification projects.
Escalate critical compliance risks and trends to Quality Leadership and lead cross-functional remediation.
Collaborate with Procurement, Supply Chain, Clinical Operations, Regulatory, Medical Affairs, and PV to ensure consistent third-party oversight.
Act as a subject matter expert for regulatory inspections related to third-party audits and qualifications, maintaining audit readiness.

Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related field
Extensive knowledge of GMP, GDP, and GCP activities, including qualification, requalification, and auditing best practices
Formal lead auditor certification required (e.g., IRCA/CQI, ISO 9001 or equivalent)
Minimum 6–7 years of experience in Quality Assurance, preferably in vendor, supplier, or audit management
Strong risk-based thinking and ability to align compliance activities with broader business objectives
Experience with clinical trial supply and unlicensed supply preferred
Excellent communication skills—both verbal and written—with a focus on audit effectiveness
Critical thinking, analytical mindset, and strong attention to detail
Self-motivated and adaptable, with excellent time management and organizational skills
Proficient in Microsoft Outlook, Word, and Excel

Global Third Party & Audit Manager

Key skills