Director of Quality Assurance

5 days ago

St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
Job Description

X4 Life Sciences is seeking a highly experienced and skilled Director of Quality Assurance to join our team.

About the Role:

  • Oversee and continually review the quality management system to ensure that improvements are identified and that any deficiencies are addressed at their root cause and appropriate procedures are developed and fully implemented.
  • Verify and ensure that the products are manufactured, packed and tested to the requirements of registered MA.
  • Review the third-party audit reports for APIs and packaging materials. Review annual product quality reviews.
  • Ensure complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with the company QMS.
  • Host MHRA inspections, write response reports and liaise with the Medicines Inspectorate to ensure that the Company conforms to the requirements of GMP and the Manufacturing and Product Licenses.
  • Develop, manage and maintain the company's device family technical files and product specific design dossiers ensuring compliance with the relevant regulations.
  • Remain up to date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
  • Approve specifications, sampling instructions, test methods, and QC procedures, including amendments.
  • Approve and monitor suppliers of raw materials and packaging components.

Additional Responsibilities:

  • Coordinate the preparation and hosting of MHRA and customer inspections as named QP.
  • Act as 'Qualified Person' in approving Finished Product for release onto the marketplace.
  • Perform QP batch certification of licensed medicines (per applicable regulations) and provide QP support as required for Quality issues.

Requirements:

  • Bachelor's or Associate degree.
  • Minimum of 5 years experience in Quality Assurance at a manufacturing site.
  • Previous experience in a leadership role.
  • Extensive Pharmaceutical Industry experience with hands-on experience in development/quality in a GxP environment.

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