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Head of Quality Assurance

2 months ago

London, Greater London, United Kingdom X4 Life Sciences Full time
Job Description

About the Role

X4 Life Sciences is seeking a highly experienced and skilled Head of Quality to join our team. As a key member of our organization, you will be responsible for overseeing and continually reviewing our quality management system to ensure that improvements are identified and implemented.

Key Responsibilities

  • Verify and ensure that products are manufactured, packed, and tested to meet registered market authorization requirements.
  • Review third-party audit reports for APIs and packaging materials, as well as annual product quality reviews.
  • Accurately record and address complaints and adverse incidents in accordance with our quality management system.
  • 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.
  • Stay 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 as Qualified Person

  • Coordinate the preparation and hosting of MHRA and customer inspections.
  • Act as Qualified Person in approving finished products for release onto the market.
  • Perform QP batch certification of licensed medicines and provide QP support as required for quality issues.

Requirements

  • Bachelor's or associate degree.
  • Minimum of 5 years of 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.