Head of Quality Assurance

1 month ago

St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time
Exciting Opportunity: Head of Quality/Qualified Person

X4 Life Sciences is seeking a seasoned Quality professional to lead our quality management system and ensure compliance with regulatory requirements.


Your Responsibilities:
  • Oversee and continually review the quality management system to identify improvements and address deficiencies at their root cause.
  • Verify that products are manufactured, packed, and tested to registered MA requirements.
  • Review third-party audit reports for APIs and packaging materials, and annual product quality reviews.
  • Accurately record and address complaints and adverse incidents in accordance with the company QMS.
  • Host MHRA inspections, write response reports, and liaise with the Medicines Inspectorate to ensure compliance with GMP and manufacturing and product licenses.
  • Develop, manage, and maintain device family technical files and product-specific design dossiers, ensuring compliance with relevant regulations.
  • Remain up-to-date with 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 for Head of Quality as QP:
  • Coordinate the preparation and hosting of MHRA and customer inspections.
  • 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.


Your Experience, Skills, and Qualifications:
  • A bachelor's or associate degree.
  • A 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.


If this opportunity aligns with your expertise and interests, please share your CV with us at e.smailes@x4lifesciences.com.

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