United Kingdom onlyAre you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical Global Third-Party and Audit Manager 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.
The Ideal Candidate:
- Analytical
- Collaborative
- Adaptable
- Proactive
What You'll Do:
- 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.
What You'll Need:
- 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
What We Offer:
Private healthcare insurance
Long-term illness Cover
Death in service cover
Salary sacrifice pension
Annual leave
Paid maternity & paternity leave
Volunteer day
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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