Job opening - Change Control Specialist in Strombeek-Bever | Randstad

summary

strombeek-bever
permanent
full-time

job category
science & research

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.

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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.

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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).
qualifications
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.

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