ABOUT THIS ROLE
Our client, an innovative gene therapy company are seeking a Quality Assurance (QA) leader with deep experience of building and leading QA teams in the pharmaceutical, biotechnology and medical device sectors. The Snr Dir/VP QA will be responsible for the strategic development and execution of the Company’s QA program, and will be accountable for the execution and administration of their Quality Systems support compliance with GxPs and Medical Device requirements (21 CFR 820, ISO 13485). The successful candidate will provide strategic direction for all QA activities and cultivate a culture of quality and shared accountability throughout the organisation.
- Provides leadership and mentorship of the QA group. Plans and oversees day-today activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
- Ensures that Quality Management System (QMS) meets standards expected by US and global Health Authorities as they relate to gene therapy medicinal products and medical devices. Leads the continued implementation of their eQMS.
- Ensures quality metrics comply with best industry standards and practices.
- Maintains effective Quality governance to meet ongoing business and compliance needs.
- Responsible for continuous improvement and continued execution of their Corrective and Preventive Action (CAPA) program.
- Ensures overall Quality and Compliance oversight for manufacturing, supply chain, nonclinical and clinical for their gene therapy and medical device portfolio. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Acts as the head of the Change Control Board (CCB) to conduct the analysis and approval of change requests.
- Assures Material Review Board (MRB) activities have been established and maintained to assure proper analysis and disposition of nonconforming products.
- Leads management review of quality activities and acts as point of contact for escalating quality issues to Executive Management.
- Serves as primary contact in during audits by Health Authorities and Notified Bodies. Responsible for internal audit program.
- Responsible for oversight of supplier/vendor quality program, including audit, change and inspection management.
THE IDEAL CANDIDATE
- Minimum 15 years’ experience in the pharmaceutical/biotechnology and medical devices industry. Extensive leadership experience in QA roles.
- Expert knowledge of Health Authority expectations and industry practices in the US and Europe as applied to medical devices and gene therapy medicines.
- Deep knowledge of FDA, ICH GXP and ISO regulations, guidelines and standards.
- Has a history of creating high-performing teams and the credibility and reputation to attract and retain talent.
- Effective negotiation, communication, listening and writing skills, including those suitable for interaction with internal and external senior management, as well as Health Authorities and Notified Bodies.
- Experience with eQMS systems. Prior experience with MasterControl desirable.
- Bachelors degree in a scientific discipline. Advanced degree preferred.
- Exceptional attention to detail and excellent organisational skills
- Ability to deal with ambiguity and flexibility to work collaboratively with others in a dynamic environment • Ability to travel, including international travel (post-Covid disruption)