Senior Manager Device Quality
A vacancy has arisen for a Senior Manager of Device Quality at a large biotech. This role is responsible for overall Medical Device Quality & Compliance leadership,from Combination Product development to commercial manufacturing. This role is based within Europe and is an exciting opportunity to over Device Quality programmes.
- Establish Quality Management Framework for Medical Device/Combination products to support compliant product lifecycle processes.
- Work according to the requirements of EU, FDA and another national Medical Device legislation (as applicable).
- Build and further develop capabilities in the organizationto enable flawless execution & good business outcomes
- Drive simplification & standardization of the QMS in line with overall quality strategies & initiatives
- Establish international and regional /local relationships with RA, other QA Groups, Manufacturing, Development and Management
- Ensure continuous regulatory knowledge as necessary for the business.
- Review and approve deviations and change controls from Suppliers and Contract Manufacturers
- Participate in Medical Device related audits and regular inspections
- Establish training curricula for QA oversight of Medical Device activities
- Write, review and approve applicable Quality System documents as needed
Skills & Qualifications
- Excellent written and oral English communication skills
- Bachelor's Degree education in Pharmaceuticals, Law, Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality/Regulatory leadership roles.
- +5 years experienced working with EU, FDA, ISO 13485, ISO 14971 and other global Medical Device regulations
- Strong collaboration skills and ability to build partnerships internally and externally
- Change management experience and influencing skills
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.