WEP Clinical

Quality Assurance Manager

WEP Clinical

full-time

Posted on:

Location Type: Hybrid

Location: Morrisville • North Carolina • United States

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality Management SystemGMPGDPrisk assessmentsdeviationschange controlCAPAbatch recordsdata integrity principleslabel control
Soft Skills
leadershipmanagementplanningorganizationmulti-taskingaccuracycoachingteam developmentcommunicationcross-functional collaboration