Quality Assurance Specialist

Company Description For a global Cell Therapy CDMO, supporting biotechnology and pharmaceutical companies in delivering transformative therapies to patients. At our Geleen facility, we focus on GMP manufacturing for advanced therapies, with a dedicated team committed to quality, safety, and compliance. Job Description As Senior QA Officer, you will play a pivotal role in maintaining and improving our Quality Management System, ensuring regulatory compliance across all operational areas. You will lead complex quality initiatives, mentor junior QA team members, and serve as the primary point of contact for key QA processes including deviations, CAPAs, and change controls. This is an excellent opportunity for a QA professional with 5 years of experience to take on a strategic and hands-on role in a dynamic GMP setting. Key Responsibilities: Lead investigations of major deviations, coordinate CAPA implementation, and review change controls for compliance and effectiveness Review and approve high-impact GMP documentation such as batch records, validation protocols, SOPs, and risk assessments Provide QA oversight during internal projects, tech transfers, and operational changes Act as a QA representative during audits and inspections, supporting both preparation and follow-up actions Conduct quality walkthroughs and QA on-the-floor checks to monitor compliance during manufacturing and QC activities Analyze QA metrics to identify trends and propose quality improvement initiatives Mentor and support development of junior QA colleagues Essential Requirements: HBO/WO degree in life sciences, biotechnology, or related discipline 5 years of QA experience in a GMP-regulated pharmaceutical or biotech environment Strong knowledge of GMP standards and regulatory requirements (EU/FDA) Experience with batch record review, sterile manufacturing, and deviation/CAPA management Demonstrated ability to lead quality investigations and process improvements Fluent in English; Dutch is an advantage Willingness to work shifts as needed to support batch disposition timelines Valid Dutch work permit required Additional Insights: Location: Geleen, The Netherlands Contract Type: Permanent Start Date: ASAP

Location: Geleen, Limburg, NL

Posted Date: 8/3/2025