Head of Quality Assurance
4 days ago
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 ensuring the highest standards of quality in our pharmaceutical manufacturing processes.
Key Responsibilities
- Oversee and continually review the quality management system to identify areas for improvement and implement corrective actions.
- Verify that products are manufactured, packed, and tested in accordance with registered MA requirements.
- Review third-party audit reports for APIs and packaging materials, and annual product quality reviews.
- Ensure complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner.
- Host MHRA inspections, write response reports, and liaise with the Medicines Inspectorate to ensure compliance with GMP and manufacturing licenses.
- Develop, manage, and maintain device family technical files and product-specific design dossiers.
- Stay up-to-date with regulatory and compliance requirements, as well as best practices in compliance control.
- Approve specifications, sampling instructions, test methods, and QC procedures.
- Approve and monitor suppliers of raw materials and packaging components.
Additional Responsibilities 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 and provide QP support as required.
Requirements
- Bachelor's or associate degree.
- Minimum 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.
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