Pharmaceutical Change Control Specialist F/M/X

Amaris Consulting; Beerse; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Amaris Consulting is seeking a Change Control Specialist to own initiating and managing change controls for innovative cell therapy projects, with a focus on CAR-T technology transfer and process improvements.

You will drive global platform enhancements, collaborate across Quality, Procurement, Planning and R&D to ensure seamless execution, and utilize Comet QMS daily to support operations. The role demands proactive ownership and strong technical writing in a dynamic environment.

Qualifications

• Experience in change control or project management within life sciences or pharmaceutical sector.
• Proficiency with Comet QMS or similar quality management systems.
• Experience or understanding of tech transfer and GMP regulations.

Responsabilités

• Initiate and manage change controls for cell therapies, including CAR-T technology transfer and process improvements.
• Drive global platform enhancements and facilitate cross-functional stakeholder engagement.
• Prepare and maintain technical documentation for change controls and process improvements.
• Collaborate with CAR-T sites in the EU and US to support process improvements and technology transfer.
• Support operational excellence within the Advanced Therapies division and contribute to executive-level work.

Connaissances

Change control

Project management

Quality systems

Stakeholder management

Technical writing

Independent work

Formation

Life sciences background

Outils

Comet QMS

Description du poste

Job Description

Join our Life Sciences team as a Change Control Specialist, where you will take ownership of initiating and managing change controls for innovative cell therapy projects. You will drive global platform enhancements, facilitate cross-functional collaboration, and ensure the successful execution of change management initiatives, with a particular focus on CAR-T technology transfer and process improvements.

Your missions

• Support change management initiatives by enabling changes to global platforms and facilitating cross-functional stakeholder engagement.
• Initiate and manage new change controls for cell therapies, with a focus on CAR-T technology transfer and process enhancements.
• Utilize Comet QMS daily to support operational activities.
• Collaborate with CAR-T sites in the EU and US to support process improvements and technology transfer.
• Prepare and maintain technical documentation for change controls and process improvements.
• Engage and network with internal and external partners to ensure clarity in business cases and change justifications.
• Work cross-functionally with Quality, Procurement, Planning, and R&D departments to ensure seamless process execution.
• Contribute to high-level executive work and support operational excellence within the Advanced Therapies division.

Your profile

• Experience in change control or project management within the life sciences or pharmaceutical sector.
• Proficiency with Comet QMS or similar quality management systems.
• Experience or understanding of tech transfer and GMP regulations.
• Academic background: life sciences, engineering, or a related field.
• English fluent. Additional language is a plus.
• You demonstrate strong technical writing and stakeholder management skills.
• You show proactive ownership, collaboration, and enthusiasm in an innovative environment.
• You are able to work independently and manage high-complexity tasks in a dynamic, fast-paced context.
• You have the ability to network and collaborate effectively within cross-functional and multicultural teams.

What We Offer

• An international community, bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

Recruitment process

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call

Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

(the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!