Senior QA Manager - Specialty Lab - Rijswijk

Senior QA Manager – Specialty Lab
Location: Rijswijk, Netherlands | Hybrid

• Are you experienced in ISO-regulated lab environments and looking to take the next step in a role that combines quality leadership, scientific rigor, and meaningful impact?

• Do you thrive in complex settings, enjoy advising cross-functional teams, and want to play a visible part in ensuring scientific excellence?

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.

Our Specialty Lab in Rijswijk plays a central role in delivering innovative diagnostic and trial logistics solutions, supporting advanced testing technologies including molecular and sequencing-based assays. This role will see you ensuring our operations meet the highest quality and regulatory standards while coaching internal teams and guiding improvement efforts.

Reporting to the QA Head Specialty Lab, you’ll work across a broad spectrum of quality domains: regulatory compliance, internal and client audits, CAPA and deviation management, and the release of CE-marked diagnostic products.

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 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.

Our aim is to transform clinical research to deliver the promise of precision and predictive medicine to help people live healthier lives. It’s our passion, expertise, and commitment to quality that drive Cerba Research. We want to change the shape of clinical development and help patients around the world get access to new treatments faster.

Why Join Us?

Cerba Research brings together a global laboratory network with specialty expertise to support clinical research. At our Rijswijk site, you’ll be part of a highly collaborative team delivering diagnostics that truly matter. You’ll have the chance to lead with autonomy, shape quality culture, and contribute to innovations that improve access to healthcare worldwide.

Global Scope – Be part of a worldwide team advancing diagnostic science and clinical innovation
Autonomy & Impact – Lead QA responsibilities in a high-complexity lab with broad ownership
Professional Growth – Gain exposure to CE-marked manufacturing, ISO compliance, and accreditation audits
Hybrid Flexibility – Work on-site 50% of the time with flexibility to manage your own schedule

How You Will Add Value
As Senior QA Manager, you’ll bring critical thinking, structure, and proactive QA support to a highly specialized diagnostics environment.

• Champion risk-based quality across regulated ISO frameworks

• Collaborate with stakeholders across functions to align on compliance and improvement goals

• Provide quality insights during audits, inspections, and strategic discussions

• Elevate QA awareness through training and knowledge sharing

Your Responsibilities

• Ensure adherence to Cerba Research policies, SOPs, and regulatory requirements

• Plan and execute internal audits in collaboration with the Global Audit & Vendor Quality team

• Host and support client and regulatory audits and inspections

• Lead CAPA, change management, and root cause analysis activities

• Support QA-driven projects and site-wide continuous improvement

• Deliver and design QA training sessions for lab staff

• Collaborate across departments to drive quality alignment and process efficiency

• Advise internal and external stakeholders on compliance and best practice

About You
You are a detail-driven, proactive QA professional with a background in diagnostics or regulated lab environments.

·       Bachelor's degree in biology, chemistry, medical technology, or a related scientific field

·       5+ years’ experience in QA within diagnostics, medical devices, or specialty lab environments

·       Expertise in ISO 13485, 15189, 17025, 9001; knowledge of GCP/GCLP/GLP/IVDR is an asset

·       Experience with batch release, CAPA, internal audits, and regulatory inspections

·       Excellent communication skills and the ability to collaborate across departments

·       Fluent in Dutch

Travel: Minimal – primarily site-based in Rijswijk with up to 50% hybrid flexibility