GenDx is hiring:

GenDx is a global leader in molecular diagnostic laboratory solutions for high resolution tissue typing of both donors and patients and monitoring transplant success. We combine our cutting-edge software solutions, reagents for DNA sequencing-based HLA typing and Chimerism monitoring strategies with our excellent customer support including a comprehensive education program. Our products are sold all over the world through direct sales and distributors. The GenDx office is based at Utrecht Science Park in The Netherlands. Since 2022, GenDx is part of the Eurobio Scientific Group, headquartered in Les Ulis, France.

With a highly educated and motivated team of about 120 colleagues, we contribute to the quality of life of transplant patients. Do you want to be part of an innovative company that offers ample time for development? To strengthen our team, we offer a challenging position for a structured, hands-on and quality-minded Quality Control Manager Reagents, who thrives in a collaborative, cross-functional and science-driven environment.

As Quality Control Manager Reagents at GenDx, you will play a key role in ensuring the quality, reliability, and compliance of our reagent products within a highly regulated environment. You understand that our products have a direct impact on patient outcomes, and that delivering consistent, top-quality results is essential. You will lead and support QC activities while working cross-functionally with teams such as production, R&D, and Quality Assurance, to continuously improve processes and uphold the highest standards.

You combine a strong scientific background with hands-on laboratory experience and a structured, detail-oriented approach. In this role, you will balance operational involvement with oversight, while contributing to projects and supporting the development of the QC team.

Responsibilities

• Oversee and coordinate daily Quality Control activities related to reagent testing and release.
• Ensure compliance with internal quality standards and external regulatory requirements (e.g. ISO13485 and IVDR).
• Lead and contribute to cross-functional projects aimed at new product implementation and process improvement, implementation, and optimization.
• Review, interpret and trend QC data, ensuring accuracy, consistency, and timely reporting.
• Support troubleshooting of complex technical issues and drive root cause analyses.
• Contribute to validation activities, including method validation and verification processes.
• Act as a key point of contact during audits and inspections and support audit readiness.
• Collaborate closely with production, R&D, process development and QA teams to ensure alignment and continuous improvement.
• Support and guide team members, fostering development and knowledge sharing within the QC team.

Requirements

• MSc or PhD in Biochemistry, Molecular Biology or a related field.
• Minimum of 3 years of experience in a QC or manufacturing laboratory within the biotech industry.
• At least 2 years of experience in cross-functional project management.
• Proven troubleshooting and analytical skills, with a structured approach to problem-solving.
• Excellent ability to maintain oversight while paying close attention to detail.
• Strong understanding of QC standards, methodologies, and validation processes.
• Experience with analytical techniques and molecular diagnostics, such as short- and long-read sequencing, amplification technologies, and associated data analysis methodologies.
• Working knowledge of regulatory frameworks such as ISO13485 and IVDR.
• Strong organizational skills and the ability to work both independently and collaboratively.
• Strong verbal and written communication skills.
• Experience with audits and inspections is an advantage.
• Experience in a QC management or supervisory role is a plus.
• Demonstrated experience with people management, or a strong motivation to develop leadership skills.
• Excellent command of English (written and spoken).
• You currently live near Utrecht Science Park or are willing to relocate within a reasonable commuting distance of the office.
• Please note that you must be legally eligible to live and work in the Netherlands. Unfortunately, visa sponsorship may not always be possible.

What do we offer?

• A team of like-minded people who all strive to deliver the highest quality products possible.
• An international working environment.
• New office facilities accommodating the GenDx café to enjoy your daily healthy lunch.
• Competitive salary.
• Pension scheme.
• Compensation for commuting traffic.
• Full-time contract (1,0 FTE) based on a 40 hour work week.
• Option to work part-time (0,8 – 0,9 FTE).
• Laptop.
• 25 holidays and a week paid Christmas leave.
• Free membership at sports center Olympos.
• Access to Employee Assistance Program ‘OpenUp’.

Information
For more information you can contact Walinka van Tol, Associate Director QC, at +31 (0)30 252 37 99.

Do we match?
Join the experts in transplant diagnostics! Do you want to be part of an innovative company that offers excellent working conditions and ample time for personal development? Apply now via the button below, and maybe you will soon be part of the GenDx team.

Unsolicited third party/agency profiles and resumes will not be considered.