QA Lead

What you will do

 

Quality oversight

• Provide QA support and expertise to iPSC cell culture, cell banking, celle differentiation in bioreactor and aseptic manufacturing activities.
• Maintain a strong QA presence on the shop floor and promote a proactive, right-first-time quality culture.
• Review and approve GMP documentation, including batch records, specifications and validation documentation.

Quality systems & risk management

• Lead and assess Change Controls, Deviations, CAPAs and Quality Risk Assessments.
• Provide risk-based quality input to manufacturing processes, equipment, systems and facilities.
• Support continuous improvement of our Quality Management System and documentation processes.

Technology Transfer & validation

• Represent QA in multidisciplinary technology transfer and process development projects.
• Ensure successful transfer of processes from R&D/development into GMP manufacturing and, where relevant, between client and Cellistic sites.
• Provide QA oversight of qualification, validation and aseptic process simulation activities.
• Ensure customer and regulatory quality requirements are appropriately reflected in processes and documentation.

Quality leadership

• Act as a trusted QA partner to operational and scientific teams.
• Coach and support colleagues in applying GMP and quality principles.
• Contribute to audit and inspection readiness and to the continued development of Cellistic's quality culture.

QP qualification/eligibility would be a strong asset, and may provide the opportunity to support the QP in batch review and release activities. It is not a prerequisite for the role.

 

What you bring

 

• Master’s degree or PhD in Life Sciences, Biotechnology, Pharmacy, Biochemistry, Biology or a related discipline.
• 5+ years of QA experience in biopharma, biotechnology, ATMPs or a related GMP environment.
• Strong experience with GMP, Quality Risk Management, Change Control, Deviations and CAPAs.
• Experience in aseptic manufacturing, cell therapy, cell banking or stem cell/iPSC platforms.
• Experience with Technology Transfer and/or process validation.
• Good knowledge of relevant EU GMP requirements, particularly for sterile/aseptic manufacturing and ATMPs.
• Experience in a CDMO environment is an advantage.
• English proficiency is essential; French is an advantage.
• Strong communication, collaboration and organisational skills, with a pragmatic and risk-based approach to quality.
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Why join Cellistic?

 

You will join a growing international biotech where quality is not simply about compliance — it is an essential part of bringing innovative cell therapies closer to patients. You will have the opportunity to work across science, development and GMP manufacturing, collaborate with highly skilled colleagues and clients, and help shape quality processes as Cellistic continues to grow.

Interested in helping us make the next generation of cell therapies possible? We would love to hear from you.

 

Interested?

Send your motivation letter with curriculum vitae to: careers@cellistic.com