Senior QA Manager

The Global Quality team at Cerba Research is looking for a Senior QA Manager, Specialty Lab to strengthen quality oversight across our Netherlands specialty lab operations, working flexibly between Rotterdam and Rijswijk. This role plays a key part in our study-based auditing programme, ensuring quality oversight keeps pace with the scale and complexity of our specialty lab work.

Responsibilities

Participate in, perform, and review audit findings and reports for study-based audits, based on intended use and endpoint; Advise and mentor QA Managers, providing support for QMS findings and their resolution during audits; Perform internal audits and support, follow up on, and host external audits and regulatory inspections, in collaboration with the Global Audit and Vendor Quality Team; Review proposed CAPA responses and work with CAPA owners to ensure adequate resolution; Detect deviations, review root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks; Aid in the preparation of local and global management review and KPIs; Independently manage QA-related projects through to completion; Strengthening study-based audit rigour across validation, analytical plans, raw data and reports; Advising on regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA and GAPIV standards; Independently managing QA-related projects and driving process improvements across the specialty lab

Requirements

University or equivalent degree in a relevant scientific field (biology, chemistry, medical technology or related), and/or 5+ years' experience in Quality Assurance and laboratory operations; In-process audit experience, with a demonstrated ability to assess and improve ongoing processes; Strong knowledge across ISO17025, ISO15189, ISO13485, ISO9001, GAPIV, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA; Comfortable working across multiple sites and open to travel between Rotterdam and Rijswijk; A natural mentor, able to coach less experienced auditors while independently managing your own workload; Fluent in English

Nice to have

Experience with study-based, bioanalytical auditing; Familiarity with ICH M10 bioanalytical method validation guidance; Dutch language skills