The Role
Lead site quality assurance for manufacturing and distribution activities, ensuring compliance with GMP/GDP and QMS. Oversee deviations, CAPAs, batch record reviews, warehouse responsibilities, risk assessments, audits, and cross-functional coordination. Coach and develop QA site team to deliver compliant clinical trial and expanded access supply services.
Summary Generated by Built In
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 forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The WEP Clinical GMDP Quality Assurance Manager will be responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. They will oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. The GMDP Quality Manager will also act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.
The Ideal Candidate:
- Attention to detail
- Proactive and self-motivated
- Calm and logical under pressure
- Confident communicator
- Strong leadership mindset
What You'll Do:
- Lead and manage day-to-day site quality assurance operations.
- Maintain and ensure compliance with the site Quality Management System (QMS).
- Ensure compliance with GMP/GDP regulations and relevant regulatory requirements.
- Oversee and ensure timely completion of quality records (e.g. deviations, complaints CAPAs and Change Controls, Customer Verification), ensuring where applicable, effective investigation and root cause analysis.
- Complete critical warehouse reviews as the Responsible Person, Deputy Responsible Person, or Equivalent Delegate, verifying warehouse maintenance programs have been completed (e.g. pest control, cleaning reports, calibration reviews).
- Conduct and oversee risk assessments to support quality and business decisions.
- Review and approve executed batch records, ensuring product packaging activities have been performed in accordance with packaging specifications and internal SOPs.
- Effectively host or delegate self-inspections, client audits and/or regulatory inspections, ensuring timely follow up to reports and robust CAPAs.
- Lead, coach, and develop the QA site operations team to drive a cohesive and highly effective team.
- Work closely with cross-functional teams (e.g. supply chain, logistics, and project teams) to ensure compliant delivery of services.
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 5+ years of related industry experience
- Proven leadership and management capabilities
- Ability to plan and organize effectively, working on multiple priorities to strict deadlines with a high level of accuracy
- Experience with UK, FDA, and EU regulations, pertinent to manufacturing and distribution operations is required
- Strong understanding of fundamental principles for core Quality Management System processes (e.g. risk assessments, deviations, change control, supplier/customer management
- Extensive knowledge of Good Manufacturing and Distribution Practice including data integrity principles and label control
- Ability to balance business need and Quality requirements, identifying ways to meet both aspects
- Excellent communication skills: verbal and written
- Ability to effectively communicate and navigate various stakeholders in management and non-management positions to drive action and project completion including explaining complex quality issues to non-quality personnel
- IT literate: Microsoft Outlook, Word, Excel is essential
- Ability to remain in a statutory position for extended periods as part of normal day-to-day activities, with reasonable adjustments considered where appropriate.
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
What We Offer:
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
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 personalized service of a specialized 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 and 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.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, 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.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/
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.
#LI-Fulltime #LI-hybrid
Skills Required
- Bachelor's degree or higher
- Degree in pharmaceutical, life sciences, or engineering (preferred)
- 5+ years related industry experience
- Proven leadership and management capabilities
- Experience with UK, FDA, and EU regulations relevant to manufacturing and distribution
- Strong understanding of core QMS processes (risk assessments, deviations, change control, supplier/customer management)
- Extensive knowledge of Good Manufacturing and Distribution Practice including data integrity and label control
- Ability to plan and organize multiple priorities to strict deadlines with high accuracy
- Excellent verbal and written communication skills
- IT literate: Microsoft Outlook, Word, Excel
- Ability to remain in a statutory position for extended periods (with reasonable adjustments)
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
