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Director of Quality Assurance and Compliance
2 months ago
X4 Life Sciences is seeking a highly experienced Quality Assurance Director to lead our Quality team and ensure compliance with regulatory requirements.
Key Responsibilities:
- Provide guidance and oversight to the Quality team, including QA Managers, to ensure effective implementation of quality systems.
- Ensure all products manufactured, packaged, and tested meet cGMP standards and regulatory requirements.
- Oversight of Contract Manufacturing Organizations (CMOs) and vendors to ensure compliance with quality and regulatory standards.
- Assure that all external products meet requirements and are in compliance with regulatory standards.
- Ensure that regulatory requirements, including Annual Product Reviews, stability management, and sample management, are in compliance for the product portfolio.
- Implement and maintain a robust Quality Management System (QMS) that meets regulatory requirements.
- Solid knowledge of cGXP and experience performing audits to ensure compliance with regulatory standards.
- Bachelor's degree in a scientific discipline or equivalent experience.
X4 Life Sciences is a leading healthcare organization dedicated to delivering high-quality products and services. As a Quality Assurance Director, you will play a critical role in ensuring our products meet the highest standards of quality and regulatory compliance.
