Quality Assurance Lead

Cellistic; Mont-Saint-Guibert; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Cellistic, based in Mont-Saint-Guibert, Belgium, seeks a QA Lead to partner with Manufacturing and Development teams, providing quality leadership from transfer and process development through GMP production of iPSC-derived therapies.

You will drive GMP documentation oversight, Change Controls, Deviations and CAPAs, and ensure alignment with EU GMP requirements and regulatory expectations on the shop floor.

Qualifications

• 5+ years QA experience in biopharma/ATMPs or GMP environments.

Responsabilités

• Quality oversight of iPSC cell culture, cell banking, bioreactor and aseptic manufacturing activities.

Connaissances

QA experience

GMP

Change Control

Deviations

CAPAs

Quality Risk Management

Technology Transfer

Process Validation

Aseptic Manufacturing

Cell Therapy

EU GMP knowledge

English Proficiency

Formation

Master’s or PhD in Life Sciences or related

Description du poste

Cellistic is an iPSC-first CDMO helping bring the next generation of cell therapies from innovation to the clinic. Based in Mont-Saint-Guibert, Belgium, we provide integrated services from iPSC cell line development and process development through GMP manufacturing and release testing.

Combining deep iPSC expertise with our proprietary Pulse™ and Cellistic Echo™ platforms, we help biotech and pharmaceutical innovators develop scalable, high-quality cell therapies more efficiently.

Our multidisciplinary teams work side-by-side across R&D and GMP manufacturing, with one shared goal: turning the promise of cell therapy into real impact for patients.

The role

In your QA Lead role, you will be a key Quality partner for our manufacturing and development activities.

You will act as a QA subject matter expert for iPSC-based and derived cell therapies manufacturing as well as cell line development, providing quality leadership from internal/external technology transfer and process development through to GMP production.

Working closely with Production, MSAT/Tech Transfer, R&D, QC and Project Management, you will support project teams to ensure process robustness, driving sound quality decisions and continued GMP compliance.

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.
• 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.

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.