WEP Clinical

Global Third Party & Audit Manager

United Kingdom
Posted 9 days ago

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Global Third Party & Audit 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.

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.

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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

The employee must be able to remain in a stationary position for extended periods.

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 biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

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 that we do to support our employees.

How We Work at WEP Clinical:

At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

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Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialisation

Data Privacy Notice:

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your data will be processed in accordance with our Terms of Use and Privacy practices: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

How to Apply:

To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.

Important Note:

To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.

For your safety, please note:

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any stage of recruitment.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Skills

Analytical
Collaborative
Adaptable
Proactive
Quality Assurance
Auditing
GMP
GDP
GCP
GLP
GVP
Risk-Based Thinking
Communication
Critical Thinking
Attention to Detail
Time Management