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      job details

      summary

        posted 23 february 2026

        reference number
        JN -022026-557527

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        randstad operational

        randstad operational

        at randstad, we take the time to understand what's really important to you. for some that means starting later, for others leaving earlier. the better we understand what you want, the better we can help you find a good work-life balance. and thus to find a job that makes you happy. we are by your side, today, tomorrow and every day of your career.

        job details
        Change Control Specialist | MSAT Advanced Therapies

        Are you ready to be at the forefront of medical innovation? In the world of Advanced Therapies, every process improvement brings us one step closer to life-changing patient outcomes. We are looking for a proactive Change Control Specialist to join our Global MSAT (Manufacturing Science and Technology) Lifecycle Management team. If you thrive in a high-tech, fast-paced environment where your technical expertise directly impacts the global scaling of CAR-T cell therapies, this is the role for you.


        ...

        The Role: Shaping the Future of Cell Therapy

        As a Change Control Specialist, you are the bridge between innovation and execution. You won’t just be managing paperwork; you will be enabling global platform changes and facilitating cross-functional engagement to ensure our CAR-T technology transfers and process enhancements are seamless. You will act as a pivotal point of contact between sites in the EU and US, ensuring that every change is technically sound, well-justified, and perfectly executed.

        show more
        Change Control Specialist | MSAT Advanced Therapies

        Are you ready to be at the forefront of medical innovation? In the world of Advanced Therapies, every process improvement brings us one step closer to life-changing patient outcomes. We are looking for a proactive Change Control Specialist to join our Global MSAT (Manufacturing Science and Technology) Lifecycle Management team. If you thrive in a high-tech, fast-paced environment where your technical expertise directly impacts the global scaling of CAR-T cell therapies, this is the role for you.


        The Role: Shaping the Future of Cell Therapy

        As a Change Control Specialist, you are the bridge between innovation and execution. You won’t just be managing paperwork; you will be enabling global platform changes and facilitating cross-functional engagement to ensure our CAR-T technology transfers and process enhancements are seamless. You will act as a pivotal point of contact between sites in the EU and US, ensuring that every change is technically sound, well-justified, and perfectly executed.


        • key responsibilities

          Your Responsibilities
          • Lead Change Initiatives: Initiate and manage complex change controls focused on CAR-T technology transfers and process enhancements.
          • Stakeholder Synergy: Facilitate engagement across Quality, Procurement, Planning, and R&D to ensure clarity in business cases and justifications.
          • Quality Excellence: Utilize the Comet QMS daily to support operational activities and maintain the highest standards of compliance.
          • Technical Documentation: Draft and manage high-level technical documentation and executive-level reports.
          • Global Networking: Build and maintain strong professional networks within the organization and with external Contract Manufacturing Organizations (CMOs).


        • qualification

          Your Profile
          • Experience: At least 2 years of relevant experience in a regulated environment (Bio-Pharma or Life Sciences preferred).
          • Expertise: Solid understanding of GMP regulations and technical writing. Experience with Comet QMS or Tech Transfer is a significant advantage.
          • Project Mindset: Proven ability to manage high-complexity tasks and projects with an organized, proactive approach.
          • Communication: Fluent in English (written and spoken) with the ability to influence and collaborate across diverse, global teams.
          • Mindset: You are an enthusiastic "owner" of your work, capable of working independently while staying connected to a remote, cross-functional team.
        • benefits

          What We Offer

          We believe in rewarding expertise with a comprehensive package that supports both your professional growth and your personal well-being:

          • Financial Security: A competitive gross salary tailored to your expertise, supplemented by a 13th-month pay and holiday allowance.
          • Net Benefits: A monthly net allowance of €155 and €160 in meal vouchers (per 20 days worked).
          • Mobility: A company car with a fuel/charging card (subject to conditions) for both professional and private use, or an attractive mileage reimbursement.
          • Health & Future: Premium DKV Hospitalization Insurance, annual Eco-cheques (€250), and a solid work-life balance with 12 additional ADV days per year.
          • Growth: Access to extensive training programs and clear career progression opportunities.
          • Culture: Active participation in team events and a dynamic, innovative working environment.