Quality Assurance Manager
WEP Clinical
Quality Assurance
Morrisville, NC, USA
Posted on Jul 10, 2025
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 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 with regulatory Good Manufacturing and Distribution Practice standards and operational improvements. The 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 respect to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.
The Ideal Candidate:
- Detail-Oriented
- Process-Driven
- Adaptable
- Collaborative
What You'll Do:
- Accountable for day-to-day site quality operations at the site, ensuring critical quality records and activities are completed in a timely manner and that patient safety and product quality is protected.
- Lead and maintain the site Quality Management System, ensuring ongoing compliance with GDP/GMP, procedural standards, and regulatory requirements (e.g. FDA, MHRA, HPRA, EMA).
- Monitor and report operational key performance indicators, identify trends, driving data-driven quality improvements and decisions.
- Provide hands-on quality oversight of the warehouse distribution and manufacturing activities.
- Complete or oversee risk assessments that drive key decisions to avoid/mitigate business and quality risks.
- Ensure warehouse floor presence where necessary, supporting supply chain and logistics team in making compliant and risk-based decisions.
- Point of escalation for site-specific issues and pro-actively mitigating issues related to product quality or patient safety.
- Attendance on site in the case of emergencies (e.g. business continuity, GxP critical issues).
- 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.
- Oversee and mentor team members in ensuring that effective quality decisions are made (e.g. robust CAPAs addressing the root cause, managing changes effectively)
- 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).
- Support in developing secondary packaging strategies for the business, co-ordinating activities with key stakeholders
- Lead, coach, and develop the QA site operations team to drive a cohesive and highly effective team.
- Line manage QA site operational personnel, coaching them and developing them to meet their own personal in line with business goals.
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, is required and may vary based on geographical considerations.
- Extensive knowledge of Good Manufacturing and Distribution Practice.
- Strong understanding of fundamental principles for core Quality Management System processes (e.g. risk assessments, deviations, change control, supplier/customer management).
- Use of initiative is essential to make day-to-day decisions and guide the site.
- Solution focused is essential, to avoid causing business disruption and ability to understand various business models and apply risk-based approaches to the site.
- Ability to take a pro-active and reactive risk-based approach with their day-to-day activities.
- Ability to balance business need and Quality requirements, identifying ways to meet both aspects.
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
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 and 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.
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, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
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.