Wepclinical1mo ago

GMDP Quality Assurance Manager

United States·MorrisvilleFull-Timemid

OtherQA & TestingQuality Assurance ManagerQuality Assurance Lead

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Quick Summary

Overview

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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.

Attention to detail

Proactive and self-motivated

Calm and logical under pressure

Confident communicator

Strong leadership mindset

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.

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.

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 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.

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.

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