Quality Assurance Director

19 hours ago


Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Description

Quality Assurance Director

X4 Life Sciences is a growing generics pharmaceutical manufacturer seeking an experienced Quality Assurance Director to oversee the quality management system, ensuring continuous improvement and compliance with GMP regulations.

Your Key Responsibilities:
  • Review and refine the quality management system to identify areas for improvement and implement procedures to address deficiencies.
  • Verify that all products manufactured, packed, and tested meet registered MA requirements, guaranteeing regulatory compliance.
  • Analyze third-party audit reports for APIs and packaging materials to ensure they meet our high standards.
  • Liaise with the Medicines Inspectorate to respond to MHRA inspections, maintain open communication, and ensure adherence to GMP and Manufacturing and Product Licenses.
  • Maintain device family technical files and product-specific design dossiers, ensuring up-to-date regulatory compliance.
  • Stay informed about evolving regulatory requirements and best practices in compliance control, applying this knowledge to drive process improvements.
  • Approve specifications, sampling instructions, test methods, and QC procedures, including any amendments.
  • Oversee supplier management, approving and monitoring raw materials and packaging components.
Requirements:
  • Bachelor's or associate degree.
  • A minimum of 5 years' experience in Quality Assurance at a manufacturing site.
  • Previous leadership experience.
  • Extensive Pharmaceutical Industry experience with hands-on experience in development/quality in a GxP environment.

The estimated salary for this role is £60,000 - £80,000 per annum, depending on experience and qualifications.



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