Job Description

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.

The Global Third-Party and Audit Manager will be responsible for the qualification, oversight, and auditing of third parties (i.e., suppliers and third-party contractors/vendors) that support the company's GxP activities, including pharmaceutical manufacturing, distribution, and clinical operations. This includes suppliers of medicinal products, medical devices, and critical third-party service providers across GMP, GDP, GCP, GLP, and GVP domains. The role ensures these partners and suppliers comply with applicable regulatory requirements and internal standards, supporting the safe, effective, and compliant delivery of critical service lines (i.e. Expanded Access Programs, Clinical Trial management and supply, and nursing operations). This position will also include management of the internal and external audit activities, ensuring appropriate oversight and compliance with the respective schedules and driving continuous improvement within these areas.
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The Ideal Candidate:

Analytical Collaborative Adaptable Proactive
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What You'll Do:

Own the global compliance monitoring programmes for all GxP third parties, ensuring they are qualified, re-qualified, or disqualified correctly and on time. These include, but are not limited to: 1)Suppliers of medicinal products and medical devices 2)Contract manufacturers (CMOs) and packagers 3)Warehousing and logistics providers (e.g., couriers, third-party logistics, freight forwarders, local importers) 4)Warehouse service providers (e.g., pest control, destruction services, equipment maintenance) 5)Home healthcare and nursing service providers 6)Local Contract Research Organisations (CROs) Page 2 of 5 o IT service providers (e.g., IT infrastructure, electronic systems, CCTV providers) o Laboratories and analytics service providers (GLP)


Maintain the existing approved supplier and vendor lists, including criticality ratings and compliance status. Strategically prioritise and effectively assess third parties in a risk-based, logical manner, driving efficiency in effective management. Assess and monitor ongoing third-party performance through audits, KPIs, deviations, complaints, and quality metrics. Ensure qualification/requalification activities are delivered in compliance with EU, UK, and FDA GxP (primarily GDP, GMP, and GCP) expectations and in accordance with standard operating procedure and regulatory requirements. Design and lead a global, risk-based GxP audit programme to evaluate compliance of third parties as required. Conduct, coordinate, or oversee GMP, GDP, GCP, GLP, and GVP audits, including remote and on-site formats, ensuring findings are risk assessed, reported, and closed with appropriate CAPAs. Drive completion and follow up on CAPAs related to external third parties or from internal stakeholders. Design, lead, and coordinate with support from key stakeholders, a risk-based internal audit programme, ensuring the timely completion of said internal audits Delegate internal and external audits, ensuring that personnel are appropriately qualified to perform respective audits. Ensure that internal audits drive compliance and proactively manage risk to the organisation. In addition, they provide continuous improvement opportunities and recommendations for the area audited. Support the development and management of Quality/Technical Agreements (QTAs) and Service Level Agreements (SLAs) in coordination with Legal and Operational leads. Ensure critical documentation, such as QTAs and licensure, remains up-to-date during qualification and requalification activities.
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What You'll Need:

Extensive knowledge of GMP, GDP, and GCP activities required. Formal certification as a lead auditor (e.g., IRCA/CQI Lead Auditor accreditation, ISO 9001 or equivalent) is required. Experience in clinical trial supply and unlicensed supply is preferred. Strong working knowledge of principles of qualification/requalification and auditing in a risk-based and logical manner that not only drives compliance but is integrated within the wider company objectives. Ability to take a risk-based approach with their day-to-day activities. Proactive and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy. Excellent communication skills: verbal and written, especially in auditing. Ability to understand various business models and service lines to effectively and strategically support the business's needs. IT literate: Microsoft Outlook, Word, and Excel are essential. Highly self-motivated with strong interpersonal skills. Ability to think critically and analyse investigations. Strong attention to detail. Effective planning and time management, organisational, and administrative skills. Remains adaptable to the business requirements. Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, or a related field. At least 6-7 years in Quality Assurance roles, ideally within vendor, supplier or audit management.

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.