GMDP Quality Assurance Manager

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.

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
• Experience with UK, FDA, and EU regulations, pertinent to manufacturing and distribution operations
• Extensive knowledge of Good Manufacturing and Distribution Practice including data integrity principles and label control
• Strong understanding of fundamental principles for core Quality Management System processes (e.g. risk assessments, deviations, change control, supplier/customer management)
• Excellent communication skills: verbal and written
• IT literate: Microsoft Outlook, Word, Excel

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

How We Work 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.

Services We Provide

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

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