Change Coordinator / Change Owner

Are you a Change Management professional with hands-on experience in regulated pharma environments? We are sourcing for a Change Coordinator / Change Owner role overseeing GxP-relevant changes end-to-end — from impact assessment through closure.

This is a cross-functional role at the center of the change lifecycle — working closely with Project Managers, System Owners, QA, Regulatory Affairs, IT, and Validation/Engineering teams.

What you'll do:

• Plan and govern changes in line with internal procedures and GxP regulations
• Lead change requests through the eQMS (TrackWise / Veeva) and the Change Panel
• Run Change Impact Assessments across systems, validation status, and regulatory commitments
• Define risk mitigation actions and Effectiveness Plans
• Support audits, inspections, and Health Authority submissions
• Drive post-release actions through to on-time, compliant closeout

What you bring:

• Degree in Pharmacy, Life Sciences, Engineering, or a related field
• Proven Change Management experience in pharma/life sciences, ideally with TrackWise or Veeva
• Solid grasp of EU GMP Annexes 1, 11, 14 & 15, ICH Q9, AMBV, and PIC/S guidelines
• Advanced German and English, written and spoken
• Comfort leading discussions with assessors, inspectors, and senior stakeholders

| WHAT CAN YOU EXPECT FROM TMC?

TMC is an international high-tech consultancy company that brings expertise to its clients to support them in realizing their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients, and we help them to be more competitive in an ever more global and faster-changing technological world.

At TMC, people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive. We offer you a challenging and stimulating work environment in which you can be the director of your career.

As an Employeneur, you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

| WHY CHOOSE FOR EMPLOYENEURSHIP?

We are truly unique thanks to our Employeneurship model, which is a true innovation for the high-technology consulting business. It is the business relationship of the 21st century for highly skilled technical professionals. It is built around 5 main pillars:

• You will have a permanent employment contract, offering you stability and security.
• You will get to know your market value and have a share in the profit your work generates, thanks to the individual profit-sharing.
• We will support you with one-on-one coaching and training designed to help you develop your entrepreneurial skills.
• The competence cell structure provides you with a strong, meaningful, and relevant network.
• The entrepreneurial lab: a playground for new ideas and a potential launch for start-ups.