At this moment I’ve a highly interesting QA Director opportunity at an international Life Science company, located in Noord-Brabant. This organisation is specialised in bioprocessing products that are sold to major life sciences and biopharmaceutical companies all over the world. The company is setting up a brand new site in Noord-Brabant and have big plans for the coming years.
As QA Director you’ll have the opportunity to get the site up and running by developing the QMS and Quality Control processes. Next to that, you’re end responsible for the day to day QA activities.
- Provide and lead quality compliance through training; foster a quality-oriented culture
- Manage the Quality Documentation system and archival process, maintain employee training
- Manage the daily Quality activities of finished products from incoming raw material release through batch record review and release of finished goods.
- Lead/administer audits of systems, processes and products to ensure compliance with ISO and customer requirements and compliance to the Quality System. H of customer and ISO registrar audits.
- Maintain supplier management program and qualifications including an annual critical supplier evaluation
- Manage and develop QA and QC staff members; plan and implement QA and QC resources to support quality related activities
- Proven experience to foster a Quality Culture across the organization
- Minimum of a Bachelor’s degree in Engineering, Biology or Chemistry degree required.
- At least 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment required. Microbiology experience required.
- Experience leading Quality audits both internally and externally; lead auditor certificate preferred.
- Enthusiastic, team player, collaborative across all departments to achieve the common goals.
ORGANISATION AND OFFER
This international organisation is known by the development and commercialization of high-value products and flexible solutions used in the process of manufacturing biological drugs.
They have a dynamic team with proven track records in the commercial and technical domain and have strategic collaborations with clinical key opinion leaders, industrial and other partnerships and experts. The organisation offers an attractive salary and benefits.
INTERESTED? Please reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or email@example.com