Wepclinical26d ago

GMDP Quality Assurance Manager

United States·MorrisvilleFull-Timemid

OtherQA & TestingQuality Assurance ManagerQuality Assurance Lead

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Overview

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical,

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OtherQA & TestingQuality Assurance ManagerQuality Assurance Lead

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.

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 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