-
Job Description
Lead the development of the Quality Assurance strategy for Vertex's product portfolio, ensuring compliance with commercial manufacturing license and clinical requirements.
The QP Director will provide expertise and leadership to the Quality Assurance team, driving the implementation of quality systems and processes to support the company's growth and expansion.
Key responsibilities include:
- Leading the Quality Assurance function to support the release of clinical and commercial products to the UK and EU markets
- Designing and implementing a talent acquisition and management strategy to support current and future product programs
- Partnering with contract manufacturers to resolve compliance issues and negotiate quality agreements
- Ensuring the implementation and maintenance of the Quality Management System (QMS)
- Providing technical leadership and advice on quality and batch certification issues
- Negotiating with regulatory agencies on behalf of Vertex
- Developing and implementing the Quality Assurance strategy, including leadership alignment and cross-functional team collaboration
- Representing Vertex in industry forums and shaping future regulatory requirements
Requirements:
- Deep understanding of EU and UK GMP requirements and industry trends
- Excellent communication and leadership skills
- Ability to work cross-functionally and foster collaboration
- Proficiency in Microsoft Office applications
- Strong leadership skills and ability to thrive in a high-throughput environment
- Ability to evaluate quality matters and make decisions using a risk-based approach
- Good understanding of cell and gene therapy
- Experience leading teams across different jurisdictions
Vertex is a global biotechnology company that invests in scientific innovation.