Stembio - Quality Assurance (QA) Expert

Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of cellular products such as CAR-T/TILs, Mesenchymal Stem Cells (MSCs), exosomes, immunotherapy products, cord blood banking and tissue grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.

We are seeking a highly skilled and motivated Quality Assurance (QA) Expert for Stembio to ensure compliance with cGMP, regulatory requirements, and company quality standards for our cell therapy products.

The QA Expert will oversee quality management systems, support regulatory audits, manage deviations, and drive continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance, risk management, and compliance within a cGMP-regulated environment.

If you are passionate about quality assurance in advanced cell therapies and have the expertise to uphold the highest standards, we encourage you to apply!

Qualifications

• Master’s degree or higher in Biology, Biotechnology, Biochemistry, or a related field.
• Minimum of 3+ years of experience in a cGMP-regulated Quality Assurance environment, preferably in cell therapy, regenerative medicine, or biopharmaceuticals.
• Strong knowledge of quality assurance principles, risk management, and regulatory compliance (EMA, TITCK, FDA, ICH guidelines).
• Experience in managing QMS, deviation handling, CAPA, and change control processes.
• Ability to interpret and apply regulatory guidelines and quality standards to ensure compliance.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and leadership skills, with the ability to work independently and in a team.
• Experience with electronic QMS, document control systems, and LIMS is a plus.

Key Responsibilities

• Ensure compliance with cGMP, EMA, TITCK, and other relevant regulatory requirements for cell therapy products.
• Develop, implement, and maintain Quality Management Systems (QMS), including deviation management, CAPA, change control, and risk assessments.
• Support and participate in regulatory inspections, audits, and internal quality reviews.
• Review and approve SOPs, batch records, validation protocols, and quality-related documents.
• Conduct investigations for deviations, out-of-specification (OOS) results, and non-conformances, ensuring timely resolution and implementation of corrective and preventive actions (CAPAs).
• Oversee the training program to ensure all personnel are adequately trained in quality procedures and regulatory requirements.
• Collaborate with cross-functional teams including Quality Control (QC), Production, and Regulatory Affairs to maintain high-quality standards.
• Monitor and improve quality metrics to ensure continuous improvement of quality systems and processes.
• Manage supplier and raw material quality assurance, including vendor qualification and material release processes.
• Ensure timely approval and release of raw materials, intermediates, and final products based on quality assurance criteria.

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