Senior Quality Assurance Director
5 days ago
Job Title: Head of Quality Assurance
Type: Permanent
Location: Hybrid
Our client, a rapidly expanding pharmaceutical organization, is seeking a highly skilled Head of Quality Assurance to join their team on a permanent basis. In this role, you will be responsible for developing and leading the QA function for the business.
Key Responsibilities:
- Lead the quality planning process to create a quality strategy that aligns with the company's goals and objectives.
- Develop, implement, and oversee the company's Quality Management System (QMS) to ensure compliance with applicable GMP, GDP, GLP, GCP, and GPvP guidelines.
- Manage the implementation and operation of electronic QMS solutions as required.
- Establish a risk-based approach for the supervision and monitoring of GxP-related activities, including the development of a governance framework with relevant metrics and measurements.
- Lead the Quality Management Review process.
- Implement and oversee a vendor management program for the qualification and monitoring of GxP vendors.
Requirements:
- Significant experience in the development, manufacturing, and quality control of sterile pharmaceuticals.
- Experience engaging with regulatory agencies (such as FDA, EMA, or national EU agencies), including managing inspections, attending scientific meetings, and addressing review questions.
- Demonstrated expertise in designing, implementing, and managing Quality Management Systems.
- Experience leading a team of QA professionals to deliver high-quality outcomes for the organization.
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