Quality Manager & QA lead
As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis. As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products
Wat ga je doen
We are looking for two professionals in Quality: a Quality Manager and a Quality Assurance (QA) lead:
As a Quality Manager you will be responsible for maintaining the day to day activities to support product manufacture, batch record review, test and release including deviation support, OOS support and root cause analysis.
- Manage the daily Quality activities of column products from incoming raw material release through batch record review and release of finished goods. Manager of the Quality team within the production site Breda.
- Establish and maintain a QC microbiology laboratory by building a robust microbiological system through ISO cleanroom cleaning validations, RODI water monitoring, and environmental monitoring and trending
- Lead/administer audits of systems, processes and products to ensure compliance with ISO 9001 and customer requirements and compliance to the Quality System
- Design, compile, analyze, trends and issue QA and QC performance metrics reports. Present summaries to senior management team during e.g. Management Reviews
- Manage and develop QA and QC staff members; plan and implement QA and QC resources to support quality related activities
- Member of the of the local Management Team
As a QA lead you will be the subject matter expecert for the QMS and management of timely release of finished products. As a QA lead you will report to the Quality Manager.
- Manage the Quality Documentation System and archival process, maintain employee training.
- Supervise direct reports which includes, setting objectives, monitoring performance and conducting reviews.
- Work with subject matter experts, area managers and QA personnel to effectively manage and execute follow up on corrective actions, deviations and non-conformances and 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.
Wat vragen wij
For this position as a Quality Manager we are looking for a bachelor or master candidate in Life Sciences with at least 7 years of experience in Quality (eg ISO9001)
- You have at least 3-5 years of experience mentoring and supervising direct reports, this can be in a manager or team lead role
- Experience leading Quality audits both internally and externally; lead auditor certificate preferred
- Experience with LEAN implementation strongly preferred
- Experience with SAP and EDMS
- Enthusiastic, team player, collaborative across all departments to achieve the common goals
- Affinity to work in a high paced start-up environment, which means being flexible, being able to deal with uncertainty and changes of direction and work and thrive in a highly dynamic environment.
For the QA lead we are looking for a bachelor/master candidate with a degree in Life Sciences
- You have at least 5 years’ work experience within Quality Assurance in an ISO 9001 certified facility or equivalent.
- Internal auditor certification is preferred.
- Experience and knowledge of IT software platforms that support Quality Management Systems.
Wat hebben we te bieden
- Both positions are long term positions, starting with a 12 months contract at the hiring company
- Competitive remuneration package, including a yearly bonus, non-contributory pension and partial compensation on your personal health insurance
- Full-time position
Waar ga je aan de slag
International company focused on advances in bioprocessing: high-value products and flexible solutions that address critical steps in the production of biologic drugs.