Rijswijk, South Holland, Netherlands · On-site
Senior QA Manager, Specialty Lab Location(s) – Netherlands (Rotterdam / Rijswijk) Do you know the difference between an audit that checks a box and one that actually protects a patient? Can you look past a clean SOP and …
Skills: Study-Based Auditing, Quality Management Systems, Regulatory Compliance, CAPA Management, Root Cause Analysis
Rotterdam, South Holland, Netherlands · Hybrid
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · Hybrid
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Rotterdam, South Holland, Netherlands · Hybrid
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · Hybrid
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Rotterdam, South Holland, Netherlands · Hybrid
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · Remote OK
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · On-site
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JD.COMRotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · On-site
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Rotterdam, South Holland, Netherlands · Hybrid
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The Senior QA Manager provides quality oversight for specialty lab operations, focusing on study-based auditing and the integrity of scientific results. They are responsible for mentoring QA Managers, managing CAPAs, and ensuring compliance with global regulatory standards.
Requires a university degree in a scientific field and at least 5 years of experience in Quality Assurance and laboratory operations. Candidates must have strong knowledge of ISO standards, GxP, and experience with in-process auditing.
Do you know the difference between an audit that checks a box and one that actually protects a patient?
Can you look past a clean SOP and ask whether the underlying science holds up?
Are you ready to build a team's confidence in study-based auditing, not just tell them to do it?
At Cerba Research, we are committed to finding the best talent to join our team. We have partnered with Vector Talent to manage the recruitment process for this role. If you're interested in applying, please direct all applications and questions to Vector Talent.
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.
With over 40 years of clinical research expertise, Cerba Research has built a unique offering of services, which includes clinical trial management, specialty lab & biomarkers services and medical devices & diagnostics offerings.
Cerba Research supports clients from research and development all the way through clinical studies and commercialization of therapies. We combine the deep therapeutic understanding and agility of a specialist with the capacity, breadth and global reach of a central lab.
Our extensive experience in central & specialty laboratory services is key to our success, allowing us to provide clients with early scientific insights that optimize protocol development.
We provide key laboratory services to biopharma, government and not-for-profit organizations, supporting clinical trials. Our global accredited laboratory network and connected logistical infrastructure covers the US, Europe, Asia-Pacific, Australia and Africa.
A Role With Real Weight – You'll be trusted to review the science itself, not just the paperwork around it. This is independent, meaningful oversight, work that has a direct line to the integrity of our results for patients and clients.
A Team Worth Building – You'll mentor and coach QA Managers, sharing your audit expertise and helping build a strong, capable team across our Netherlands sites.
Flexibility With Purpose – Working across Rotterdam and Rijswijk, you'll bring consistency and strong QA practice to both teams.
A Function on the Move – Global Quality at Cerba Research is actively investing in this capability. For someone who wants to build, not just maintain, there's real scope here.
As Senior QA Manager, Specialty Lab, you will contribute to:
Strengthening study-based audit rigour across validation, analytical plans, raw data and reports, ensuring findings are accurate and defensible
Mentoring and coaching QA Managers, supporting their development in QMS findings resolution and audit practice
Advising on regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA and GAPIV standards
Independently managing QA-related projects, driving process improvements across the specialty lab
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
You're an experienced QA professional who understands that a compliant process and a scientifically sound result aren't always the same thing. You're comfortable holding that line, and you know how to bring others along with you rather than simply telling them what to do.
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
Experience with study-based, bioanalytical auditing is highly valued; familiarity with ICH M10 bioanalytical method validation guidance is a strong plus
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; Dutch is an advantage
Regular travel between Rotterdam and Rijswijk required.
Transforming Research, Advancing Health Together
At Cerba Research we provide world-class clinical research to help life science companies successfully develop the predictive and precision medicines of the future and help people live healthier lives. We are committed to delivering the next generation of healthcare by transforming research and advancing health together. We support you with industry-leading excellence in oncology, virology, vaccine development, immunology, and cell and gene therapy, together with world-class deep specialty testing, from next generation sequencing to flow cytometry, molecular diagnostics, IHC & and spatial Omics, and bioinformatics. We are committed to helping you deliver the next generation of human-centric healthcare, by transforming research, and advancing health together. Uniquely, we combine the experience of specialty laboratories with the global reach of a central lab. We have a worldwide network of 1000 labs, hold data from over 85 million patients across five continents, and have the ability to sequence 1000-plus whole human genomes per week. This unparalleled approach to patient data gives you the opportunity to have one partner for all your test services, with consistent access and support across all clinical trial phases.
Offices: Industriepark Zwijnaarde, 3, Ghent, Flemish Region 9052, BE · 7-11 Rue de l'Équerre, Saint-Ouen-l'Aumône, 95310, FR · 5 Delaware Drive, Long Island, New York NY 11042, US · 126, Rue Émile Baudot, Montpellier, Occitanie 34000, FR · Montgomery Street 50, Kogarah, Kogarah NSW 2217, AU
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