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GMDP Quality Assurance Manager

WEP Clinical·See all WEP Clinical jobs on Jobr

Posted 3 months ago

OfficeMorrisville, North Carolina, USSE

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 organisation dedicated to advancing clinical research and transforming lives.

Role Objectives:

The WEP Site 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 Site 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 organise 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

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.

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 the District of Columbia.

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Job details

Workplace

Office

Location

Morrisville, North Carolina, US

Experience

WEP Clinical

View company page

WEP is the Complete CRO | we help Sponsors advance their much-needed medicines and get them to patients worldwide | Clinical Trial Management | Treatment Access Solutions | Market Access and Commercialization

Website LinkedIn +3

Employees

344

Industry

Research Services

Headquarters

London

Founded

2008

Company location

The Lightbox, Unit G.07, 111 Power Road, London, W4 5PY, GB

Specialties

Pharmaceutical Supply, Clinical Trial Services, Import, Export and Distribution of Pharmaceuticals, Expanded Access Programs, Post-Trial Access Programs, CRO Services, Mobile Nursing, Early Access Programs, Market Access Consulting, Clinical Trials, and Clinical Trial Management

Key team members

Steve Brown

Karl Challender

Nicole Pryse

Brian-Patrick T.

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