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 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.
About Cerba Research
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.
Why Join Us?
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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.
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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.
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Flexibility With Purpose – Working across Rotterdam and Rijswijk, you'll bring consistency and strong QA practice to both teams.
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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.
How You Will Add Value
As Senior QA Manager, Specialty Lab, you will contribute to:
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Strengthening study-based audit rigour across validation, analytical plans, raw data and reports, ensuring findings are accurate and defensible
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Mentoring and coaching QA Managers, supporting their development in QMS findings resolution and audit practice
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Advising on regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA and GAPIV standards
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Independently managing QA-related projects, driving process improvements across the specialty lab
Your Responsibilities
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Participate in, perform, and review audit findings and reports for study-based audits, based on intended use and endpoint
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Advise and mentor QA Managers, providing support for QMS findings and their resolution during audits
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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
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Review proposed CAPA responses and work with CAPA owners to ensure adequate resolution
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Detect deviations, review root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks
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Aid in the preparation of local and global management review and KPIs
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Independently manage QA-related projects through to completion
About You
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.
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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
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In-process audit experience, with a demonstrated ability to assess and improve ongoing processes
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Strong knowledge across ISO17025, ISO15189, ISO13485, ISO9001, GAPIV, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA
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Experience with study-based, bioanalytical auditing is highly valued; familiarity with ICH M10 bioanalytical method validation guidance is a strong plus
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Comfortable working across multiple sites and open to travel between Rotterdam and Rijswijk
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A natural mentor, able to coach less experienced auditors while independently managing your own workload
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Fluent in English; Dutch is an advantage
Travel:
Regular travel between Rotterdam and Rijswijk required.
At Cerba HealthCare, we believe that the diversity of people, backgrounds, and perspectives is an essential asset in fulfilling our mission: to improve the health of everyone, everywhere.
We are committed to providing an inclusive work environment that guarantees equal opportunities for everyone, regardless of age, background, sexual orientation, disability, or any other personal characteristic. All talented individuals are encouraged to apply.
