About this role
Bewaar Senior QC Systems Specialist QC Systems Specialist I Amsterdam | QC Systems Specialist | GMP As Senior Specialist I - Quality Systems, you will support the deployment, governance, maintenance, and continuous improvement of Kite Pharma's Quality Management System. Acting as a compliance partner across multiple departments and stakeholders, you will ensure site quality systems remain compliant with GMP regulations, regulatory requirements, and Kite quality standards.
Key Responsibilities
- Manage and maintain Quality Systems including Change Control, Deviation, CAPA, and Material Review Board (MRB) processes.
- Deliver Quality Systems training and support user adoption across the site.
- Act as backup chair for the Change Control Review Board, Deviation Board, and Material Review Board.
- Monitor site compliance through metrics, governance activities, and management reporting.
- Review and approve changes, deviations, CAPAs, and quality system documentation.
- Support regulatory inspections, internal audits, and quality system assessments.
- Ensure proper maintenance of cGMP documentation and Quality Management System records.
- Identify and mitigate quality risks in accordance with regulatory guidelines and company procedures.
- Lead or support cross-functional quality initiatives and site start-up activities.
- Drive continuous improvement projects within Quality Systems processes.
- Support automated reporting tools and workflows when required.
- Provide day-to-day guidance to team members and act as backup to the Senior Manager Quality Systems.
What you'll need to succeed The successful candidate will hold a degree in Life Sciences, Bio‑Engineering, or a related field, with a background in GMP‑regulated QC laboratory work.
Key requirements include
- Strong knowledge of GMPs, pharmaceutical Law and legislation
- Experience with Change Control, CAPA, Internal Audit, Deviations, MRB and other ICHQ10 quality system...