Validation Specialist

Hartwig Medical Foundation; Amsterdam; On-site; EUR 39,000 - 61,000; Full time

Benefits offered by this job

Salary range €3,500–€5,500 gross/mo

26 vacation days

Pension plan (two-thirds employer)

Office lunches Tue/Thu

Friday drinks

Annual team events

Meaningful, mission-driven work

Job summary

Hartwig Medical Foundation is seeking a Validation Specialist to develop and oversee validation activities, ensuring compliance with regulations and quality standards across the organization.

You will lead verification and validation projects, support QMS activities, and train colleagues in established workflows and guidelines. A strong quality culture and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• At least 7 years of relevant professional experience.
• Experience with quality management systems and accreditation standards (ISO 17025/15189/13485).
• Experience in accredited clinical or diagnostic environments.
• Proven ability to design, execute and coordinate validation projects.
• Knowledge of relevant regulations and quality standards.

Responsibilities

• Develop, implement and maintain validation workflows per applicable regulations and quality standards.
• Monitor and support verification and validation projects from a regulatory and quality perspective.
• Review and approve verification and validation reports to ensure compliance with regulatory requirements and clinical standards.
• Train and support colleagues involved in verification and validation activities on established workflows, procedures and guidelines.
• Keep up to date with changes in relevant regulations and translate these into our quality processes.
• Support broader Quality Management System (QMS) activities, including document control, change management and other quality-related processes.

Skills

Quality management

Regulatory knowledge

Validation projects

Analytical mindset

Cross-functional teamwork

Organizational skills

Integrity

Education

Bachelor's degree in Life Sciences

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.