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Head of Quality Assurance
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 ensuring the highest standards of quality in our pharmaceutical manufacturing processes.
Key Responsibilities:
- Quality Management System: Oversee and continually review our quality management system to identify areas for improvement and implement corrective actions to address any deficiencies.
- Product Quality: Verify that our products are manufactured, packed, and tested to meet the requirements of our registered manufacturing authorization.
- Third-Party Audits: Review third-party audit reports for APIs and packaging materials to ensure compliance with regulatory requirements.
- Complaints and Adverse Incidents: Ensure that complaints and adverse incidents are accurately recorded and addressed in a thorough and timely manner in accordance with our quality management system.
- Regulatory Compliance: 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.
- Technical Files and Design Dossiers: Develop, manage, and maintain our device family technical files and product-specific design dossiers to ensure compliance with relevant regulations.
- Regulatory Updates: Remain up-to-date with impending changes and developments regarding regulatory and compliance requirements as well as evolving best practices in compliance control.
- Supplier Management: Approve and monitor suppliers of raw materials and packaging components.
Additional Responsibilities as Qualified Person:
- Inspection Coordination: Coordinate the preparation and hosting of MHRA and customer inspections.
- Product Release: Act as the named Qualified Person to approve finished products for release onto the marketplace.
- QP Batch Certification: Perform Qualified Person batch certification of licensed medicines and provide QP support as required for quality issues.
Requirements:
- Education: Bachelor's or associate degree.
- Experience: Minimum of 5 years of experience in quality assurance at a manufacturing site.
- Leadership Experience: Previous experience in a leadership role.
- Pharmaceutical Industry Experience: Extensive experience in the pharmaceutical industry with hands-on experience in development/quality in a GxP environment.
