QA Manager, Specialty Lab — Hands-On Auditing in Rotterdam

Viroclinics-DDL; Rotterdam; On-site; EUR 80,000 - 110,000; Full time

Job summary

Cerba Research in Rotterdam is seeking a QA Manager, Specialty Lab to strengthen quality oversight at a high-volume site. This 12-month fixed-term role offers hands-on auditing across validation, analytical data and reports.

You will lead study-based audits, support CAPA processes, and help drive continuous improvement within ISO13485/ISO15189/ISO17025 and related standards. Collaboration with a senior QA manager and cross-functional teams is essential.

Qualifications

• Bachelor's degree in a relevant scientific field
• 5+ years' experience in Quality Assurance and laboratory operations
• Experience performing internal audits and supporting external audits or inspections
• Familiarity with ISO17025, ISO15189, ISO13485, ISO9001, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA

Responsibilities

• Participate in, perform, and review audit findings and reports for study-based audits.
• Perform internal audits and support, follow up on, and host external audits and regulatory inspections.
• Review proposed CAPA responses and work with CAPA owners to ensure adequate resolution.
• Detect deviations, support root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks.
• Monitor document control processes, ensuring records are created, revised and maintained appropriately.
• Provide ongoing education to staff on quality-related topics.
• Participate in QA-related projects, supporting timely completion of objectives

Skills

Quality Assurance

Lab operations

Audit experience

ISO standards

GxP awareness

English fluency

Education

Bachelor's degree in a relevant scientific field

Job description

Cerba Research in Rotterdam is seeking a QA Manager, Specialty Lab to strengthen quality oversight at a high-volume site. This 12-month fixed-term role offers hands-on auditing across validation, analytical data and reports.

You will lead study-based audits, support CAPA processes, and help drive continuous improvement within ISO13485/ISO15189/ISO17025 and related standards. Collaboration with a senior QA manager and cross-functional teams is essential.