Job Title: Quality Assurance, Global Third Party & Audit Manager
Job Type: Full-time, Permanent
Location: West London, UK - Hybrid/ Remote
Remuneration: £55,000 - £65,000 + benefits
Cpl Life Sciences is collaborating with a growing CRO that encourages innovation and collaboration, challenging its teams to bring ideas that make a real difference.
The business is looking for a Global Third-Party and Audit Manager who is responsible for the qualification, oversight, and auditing of third-party suppliers and vendors supporting GxP activities, including pharmaceutical manufacturing, distribution, and clinical operations. This includes providers across GMP, GDP, GCP, GLP, and GVP domains.
The role ensures partners meet regulatory requirements and internal standards to support the safe and compliant delivery of key service lines, such as Expanded Access Programs, clinical trial management and supply, and nursing operations. It also oversees internal and external audits, ensuring adherence to audit schedules and driving continuous improvement. This role plays a key part in the company’s vendor governance and compliance monitoring framework through risk-based oversight and cross-functional collaboration.
Role Responsibilities:
* 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.
Requirements:
* 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.
This role is remote based however you MUST be based and living in the UK with the full right to work. For more information, please reach out to me at lucy.kirkaldy@cpl.com