GMDP Quality Assurance Manager
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); Complete critical warehouse reviews as the Responsible Person, Deputy Responsible Person, or Equivalent Delegate; Conduct and oversee risk assessments to support quality and business decisions; Review and approve executed batch records; Effectively host or delegate self-inspections, client audits and/or regulatory inspections; Lead, coach, and develop the QA site operations team; Work closely with cross-functional teams (e.g. supply chain, logistics, and project teams) to ensure compliant delivery of services.
Required skills
Attention to detail; Proactive and self-motivated; Calm and logical under pressure; Confident communicator; Strong leadership mindset; Experience with UK, FDA, and EU regulations; Strong understanding of fundamental principles for core Quality Management System processes; Extensive knowledge of Good Manufacturing and Distribution Practice including data integrity principles and label control; Excellent communication skills; IT literate (Microsoft Outlook, Word, Excel).
Preferred skills
Bachelor's Degree or higher in pharmaceutical, life sciences, or engineering concentration.
Seniority
Manager.
Domain
Clinical Research / Pharmaceutical Manufacturing and Distribution.
