About the roleThe 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 CandidateAnalyticalCollaborativeAdaptableProactiveWhat You'll DoOwn 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 NeedBachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related fieldExtensive knowledge of GMP, GDP, and GCP activities, including qualification, requalification, and auditing best practicesFormal 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 managementStrong risk-based thinking and ability to align compliance activities with broader business objectivesExperience with clinical trial supply and unlicensed supply preferredExcellent communication skills—both verbal and written—with a focus on audit effectivenessCritical thinking, analytical mindset, and strong attention to detailSelf-motivated and adaptable, with excellent time management and organizational skillsProficient in Microsoft Outlook, Word, and ExcelWhat We OfferPrivate healthcare insuranceLong-term illness CoverDeath in service coverSalary sacrifice pensionAnnual leavePaid maternity & paternity leaveVolunteer dayWhat Sets Us ApartWEP 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 TeamWEP has many initiatives to encourage wellness, growth, development, and team relationships.We're Committed to DEIAt 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 includeAccess ProgramsClinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and CommercialisationWork environment & equal opportunityWEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer and makes reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
