Head of Quality Assurance (m/f/x) | Pharma/MedTech
This position will focus on managing the QA team and activities at the assigned manufacturing site. As a Head of QA, you will be responsible for coordinating the implementation of the quality and regulatory relevant regulations, standards and guidelines and procedures including documentation on site. You will enable the Quality organization to handle Deviation, evaluate NCR-results, process CAPAs and Change Controls and manage all other quality related procedures. Moreover, you will in charge of guaranteeing the status « ready for inspection » on site.
What are your tasks as a "Head of Quality Assurance (m/f/x)"?
- Manage QMS and relevant regulatory activities in accordance with applicable standards and regulation and guarantee the application of ISO13485, MDSAP & 21CFR part 820
- Manage key Quality processes at the assigned site (NCMR, CAPA, Change Control, Documentation control, Production Batch record review…) as required by the applicable QMS
- Organize and ensure proper QA related training to assigned manufacturing site employees
- Interact with contractors to ensure continuous and proper services in QC, Metrology, In-coming goods control and release, maintenance, engineering…
- Ensure relevant applicable QA agreements are constantly active and updated
- Provide necessary documentation to constantly ensure on time release of batches from assigned site
- Provide relevant QA support and guidance to manufacturing operations of assigned site for any QA related questions within manufacturing activities
- Participate to the establishment and execution of internal audits program & support Head of Quality and Compliance during audits & inspections
What requirements do you need to be a "Head of Quality Assurance (m/f/x)"?
- Master / Engineer's degree in a biomedical / scientific / law field
- At least 5 years' experience in Quality ideally in the pharmaceutical/medical devices industry (development, manufacturing)
- Knowledge of European, American, Australian and Canadian standards, laws and guidelines applicable to medical devices or pharmaceutical products
- Strong knowledge of management of quality system (21 CFR part 820, ISO13485, MDSAP)
- Experience working in a GMP environment
- Fluency in German and English (French is a plus)
Information about our client:
Founded over 100 years ago, our client is a privately held company based in Germany with affiliates across Europe, as well as the US, Canada, Mexico, Brazil and Asia Pacific with approximately 3,000 employees worldwide. The company is active in research, development and distribution of innovative products in the areas of aesthetic medicine and neurologically induced movement disorders.