He/She will set-up the infrastructure, tools and QA team supporting the manufacturing and analytical activities for this project by the review and approval of quality-related documents. He/She will also line manage the Quality Control Director and advise on the QC activities.
In addition, and importantly, the Quality Unit Director will be the key driver to establish a quality culture within the company.
- Strong and current knowledge of cGMP compliance and strong cGMP Compliance in the activities of the CMC function, related to cell and gene medicinal products.
- Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions.
- Proactively identifies and addresses potential QA problems related to the successful delivery of CMC service.
- Strong leadership/team management skills and experience.
- Credible and confident communicator (written and verbal) at all levels.
- Strategic thinker with the ability to influence at a senior level.
- Highly customer focused.
- Excellent project management skills.
- First class presentation skills (written and verbal).
- Hands-on approach, with a ‘can do’ attitude.
- First class organizational skills.
- Ability to prioritize, demonstrating good time management skills.
- Highly Desirable: Knowledge of pharmaceutical and/or biotechnology principles
Qualifications and training requirements
- Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
- Eligibility to be a Qualified Person in accordance with directive EC/2001/83 is a plus.
- Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Knowledge in Cell and Gene Therapy, specifically Plasmids and Vectors for use in licensed medicines.