QA Manager, Start-Up ATMP Biotech
A large biotech in London has partnered with Proclincial in search for a Quality Assurance Manager. This organisation has created a technology which automates cell and gene therapy. This would the perfect opportunity to flourish at an established well know biotech.
- Support the development team in ensuring the quality and safety of the Ori platform
- Manage all activities related to quality audits (internal and external including by Notified Body/FDA)
- Responsible for the independent review and approval of project documentation as required by QMS
- Support focus on quality at highest level of organization through organizing and leading regular Quality Updates for Senior Management
- Build and support a culture of compliance through frequent and clear communication of quality policy and standards at levels within the organization
- Ensure training/adherence/compliance of personnel to the QMS processes and procedures
- Participate with colleagues / consultants to establish required QMS activities and planning
- Provide guidance on applicable standards for development projects
- Provide guidance on regulatory strategy and route to market/classification (alongside Head of Regulatory).
- Support the team with improvements for the QMS to ensure compliance with relevant standards and
- Experience and understanding of working with therapeutics, working within a QMS context
- Proven expertise in highly quality controlled environments with safety critical development
Skills and Requirements
- Relevant degree in a Life Sciences Discipline (e.g. Biology, Molecular Biology, Biotechnology etc.)
- Appropriate Quality Management training and experience in managing a QMS with knowledge of relevant standards (e.g. ISO, GAMP5 etc)
- 3-5 years' experience in a similar environment
- Desire to work in an agile, fast paced and entrepreneurial environment
- IT literate, familiar with document management systems, solid XLS, PPT and presentation skills
- Fluent English speaker, second language always a plus (French, German, Italian and/or Japanese preferred) if possible
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.