At this moment I’ve a highly interesting QA Lead 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 site in Noord-Brabant and have big plans for the coming years.
In this position you’ll manage, mentor and motivate direct reports and actively participate in the QMS. Next to that, you’ll work closely with other departments like the manufacturing team.
- Subject Matter Expert for Repligen Quality Management Systems and product line.
- The management of timely release of finished good products.
- Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews.
- Works with Subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances, complaints.
- Assist with compliance audits (customer, supplier, internal, external).
- Manages daily schedule and communicates with peers and management for completion of tasks associated with product release.
- Gathering of KPIs for weekly and monthly senior management meetings.
- Final approval of quality investigations.
- Assist with the Product/Process Change Control process.
- Ability to lead quality meetings with multi-functional departments/individually to identify product.
- Ability to identify, detect and escalate quality related trends.
- Assist with the maintenance of the Repligen Quality Management Systems, as assigned.
- Bachelor’s degree in Biological Science or other science related discipline.
- Minimum 5-7 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
- Ability to communicate with multiple departments and direct reports.
- Proficient in written and oral presentations skills.
- Lead/Internal auditor certification preferred.
- Experience and knowledge of IT software platforms that support Quality Management Systems.
- Understanding of Good Documentation Practices preferred.
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? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org