Hybrid Quality Assurance Manager

at WEP Clinical

• Job title: Quality Assurance Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Morrisville, United States

About the role

• GMDP Quality Assurance Manager responsible for quality assurance operations and compliance at WEP Clinical in North Carolina. Leading site operations, team development, and regulatory adherence.

Responsibilities

• 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.

Requirements

• 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.
• IT literate: Microsoft Outlook, Word, Excel is essential

Benefits

• 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