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Validation Specialist

Hartwig Medical Foundation

Amsterdam
Full-time
5-10 years experience
On-site

€3,500 - €5,500 per month

Key Skills

Validation
Quality management systems
ISO 17025
ISO 15189
ISO 13485
Regulatory compliance
Quality assurance
Document control
Change management
Clinical diagnostics
Analytical skills
Project management
Risk management
Genomic diagnostics

Job Description

Your mission

Would you like to contribute to Hartwig’s mission to improve care for patients with cancer?

At Hartwig Medical Foundation (Hartwig), we are dedicated to improving care for patients with cancer through high-quality genomic diagnostics and data. Quality, reliability, and compliance are at the heart of everything we do.To strengthen our Quality team, Hartwig is looking for an experienced Validation Specialist. In this role, you will be responsible for developing and overseeing validation activities across the organization. You will ensure that validation projects comply with applicable regulations and quality standards while supporting colleagues in maintaining an efficient and compliant validation process.

What you will do

As our Validation Specialist, you will play a key role in ensuring that our validation processes meet the highest quality and regulatory standards. Your responsibilities will include:

  • Developing, implementing and maintaining validation workflows in accordance with applicable regulations and quality standards.
  • Monitoring and supporting verification and validation projects from a regulatory and quality perspective.
  • Reviewing and approving verification and validation reports to ensure compliance with regulatory requirements and clinical standards.
  • Training and supporting colleagues involved in verification and validation activities on established workflows, procedures and guidelines.
  • Keeping up to date with changes in relevant regulations and translating these into our quality processes.
  • Supporting broader Quality Management System (QMS) activities, including document control, change management and other quality-related processes.

Your profile

What you bring

You are a quality professional with a structured and analytical approach to your work. You enjoy collaborating with others, communicate with integrity, and understand the importance of maintaining high-quality standards in a regulated environment. You are able to see both the bigger picture and the finer details, work effectively across teams, and confidently promote a strong quality culture throughout the organization.

In addition, you have:

  • A Bachelor's degree in Life Sciences or a related field.
  • At least 7 years of relevant professional experience.
  • Experience working with quality management systems and accreditation standards, preferably ISO 17025, ISO 15189 and/or ISO 13485.
  • Experience working in an accredited environment, ideally within a clinical or diagnostic setting.
  • Proven experience in designing, executing and coordinating validation projects.
  • A solid understanding of, or the ability to quickly acquire knowledge of, relevant regulations and quality standards.
  • Excellent organizational skills, with the ability to effectively prioritize work and manage multiple projects simultaneously.
  • A high level of integrity, a strong sense of responsibility and a commitment to maintaining the highest quality standards.

Why us?

What we offer

  • A meaningful position (32–40 hours per week) within a mission-driven, non-profit organization.
  • The opportunity to work at the intersection of life sciences, data and technology in a rapidly evolving field.
  • A collaborative, open and informal working environment where knowledge sharing and initiative are encouraged.
  • A monthly salary between EUR 3,500 and EUR 5,500 gross, based on experience and skills.
  • 26 vacation days (based on full-time employment).
  • A pension plan to which Hartwig Medical Foundation contributes two-thirds of the premium.
  • Complimentary office lunches on Tuesdays and Thursdays, Friday afternoon drinks, and annual team events.

Apply! 

Are you excited about this position? Then apply by clicking the ‘apply’ button. If you have any questions about the vacancy, you can email [email protected]. The application process includes an online introduction meeting, a presentation and on-site interview, an online motivation assessment, and a reference check.

About us

At Hartwig Medical Foundation, every day we work with one clear goal: to ensure that every patient with cancer receives the treatment best suited to their unique situation. We achieve this by developing comprehensive DNA testing that helps hospitals analyze tumors with precision and supports clinicians in making informed treatment decisions. At the same time, we are building a rich knowledge base on patients, tumors, and treatment outcomes, so that the care delivered today contributes to the breakthroughs of tomorrow.

Our organization is driven by both data and people. We collaborate closely with hospitals, researchers, and partners across the Netherlands to lower the barriers to personalized cancer care. Join our multidisciplinary team of experts — including medical professionals, analysts, bioinformaticians, and software developers — and help us make a real impact on patient care.

Learn more about our organization at hartwigmedicalfoundation.nl.

Location: Science Park 408, 1098 XH, Amsterdam, Netherlands


We do not consider collaborations with agencies or freelancers for this position.



Core Responsibilities

The Validation Specialist will develop, implement, and maintain validation workflows while ensuring compliance with regulatory and quality standards. They will also support the broader Quality Management System and provide training to colleagues on established procedures.

Requirements

Candidates must hold a Bachelor's degree in Life Sciences and possess at least 7 years of professional experience in a regulated environment. Proficiency with quality management systems and accreditation standards such as ISO 17025, ISO 15189, or ISO 13485 is required.

Benefits

  • Pension plan
  • 26 vacation days
  • Complimentary office lunches
  • Friday afternoon drinks
  • Annual team events

About Hartwig Medical Foundation

Industry: Research Services

Company size: 51-200 employees

Hartwig Medical Foundation is a non-profit organization with the mission to improve cancer patient care. We support treatment decisions through a combination of innovative software, clinical data analyses, and molecular diagnostics. This enables patients to timely receive the right treatment, while generating valuable data that supports research and the continuous improvement of care. What do our colleagues think of their work at Hartwig? Some statements: “I work here because I want to help improve society.” “It is nice to work in a team of very experienced developers. Daily, we work with our partners in Australia, Canada and Spain.” “We work closely with scientists.” “The atmosphere is informal.” “The pace is fast, we have high standards. We are focused on the content and avoid unnecessary processes as much as possible. We are very flexible. If it turns out that a different way of working is better, we can quickly adapt.” “The balance between pace and relaxation is important.” “My ideas are appreciated.”

Added 1 months ago