Validation Specialist at Hartwig Medical Foundation

Amsterdam, North Holland, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

5500.0

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Workflow Development, Regulatory Compliance, Quality Management Systems, ISO 17025, ISO 15189, ISO 13485, Verification and Validation Reporting, Document Control, Change Management, Project Coordination, Analytical Thinking, Clinical Diagnostics

Industry

Research Services

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 people@hartwigmedicalfoundation.nl. 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.

Responsibilities

Develop and oversee validation activities and workflows to ensure compliance with regulatory and quality standards. Support the Quality Management System through document control, change management, and training colleagues on validation procedures.