Wepclinical9mo ago

Global Third Party & Audit Manager

United KingdomRemoteFull-Timemid

Finance & AccountingOtherIT & AdministrationAudit Manager

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Overview

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical,

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Finance & AccountingOtherIT & AdministrationAudit Manager

Are 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.

Analytical

Collaborative

Adaptable

Proactive

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