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Quality Management Lead
2 months ago
Job Summary:
X4 Life Sciences is seeking a highly experienced and skilled Head of Quality Assurance 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:
- Oversee and continually review the quality management system to ensure that improvements are identified and implemented.
- 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, and review annual product quality reviews.
- Ensure complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with our quality management system.
- Host MHRA inspections, write response reports, and liaise with the Medicines Inspectorate to ensure compliance with Good Manufacturing Practice (GMP) and manufacturing and product licenses.
- Develop, manage, and maintain device family technical files and product-specific design dossiers to ensure compliance with 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 quality control 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 Qualified Person batch certification of licensed medicines (per applicable regulations) and provide Qualified Person 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.
