QA Lead

QA Lead

Cellistic

Mont Saint Guibert, Belgium

What you will do

Quality oversight

• Provide QA support and expertise to iPSC cell culture, cell banking, cell 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.