Director, Qualified Person Job Description General Summary: The QP Director role is responsible for providing expertise and leadership to the QP team. This leadership role is also responsible for the development of the QP strategy for the Vertex product portfolio and building the QP organization to support this strategy. Ensures that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products in accordance with the requirements.
Acts as the primary point of contact for regulatory agencies in relation to batch certification activities and associated licenses. Is a member of the International Quality leadership team. This role will require travel to the UK and US as required.
Key Duties and Responsibilities: Responsible for leading the Vertex QP function supporting Vertex clinical and commercial product portfolio release to the UK and EU markets. Designing the QP talent acquisition and management strategy to support current and future Vertex product programs and supply in UK and EU markets. Partners with critical contract manufacturers to escalate and resolve compliance issues in clinical and commercial supply chains, interfaces with customer/partner quality organisations, and negotiates third party contractor and supplier quality agreements. Ensure that the QMS implemented and maintained, including the management of authorised activities and quality of records. Provide technical leadership and advice for key quality/ batch certification issues. Negotiation with regulatory agencies on behalf of Vertex regarding matters relating to QP batch certification and license related matters. Develop and implement the QP strategy for the organisation, including but not limited to: creating the framework for leadership alignment on decisions regarding QP release strategy for all Vertex clinical and commercial programs. advising cross functional teams and leaders of QP related matters. Providing the future QP direction and forum for alignment for clinical and commercial programs. Ensure Manufacturers Importation Authorisation (MIA) licenses accurately reflect the current organisation activities. In-depth and comprehensive understanding of QP/ batch certification concepts and principles expanding to QP integration with all facets of the organization/ industry sector. Representing Vertex QP organisation in this forum and shaping future regulatory requirements in QP space. Member of international Quality Leadership team and Global QP Governance Committee representing QP team. Knowledge and Skills: In-depth regulatory agency knowledge and experience in EU and UK GMP requirements with current knowledge of industry trends and best practices. Excellent communication skills. Work cross-functionally with all levels to foster exceptional collaboration. Proficiency in using Microsoft Office applications required. Strong leadership skills with the ability to thrive in a high throughput environment. Ability to evaluate quality matters and make decisions utilizing risk-based approach. Good understanding of cell and gene therapy. Experience in leading teams across different jurisdictions. Education and Experience: Bachelor's degree. Ability to act as a Qualified Person in accordance with the EU Guide to Good Manufacturing Practice in article 51 of Directive 2001/83/EC. Extensive experience as a QP and leading QP teams. Company Information Vertex is a global biotechnology company that invests in scientific innovation.
#J-18808-Ljbffr