Stembio - Head of Quality Control

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 an experienced and strategic Head of Quality Control for Stembio to lead and oversee all quality control (QC) activities for our cell therapy products.

This role is responsible for ensuring the accuracy, reliability, and compliance of QC testing, maintaining product integrity, and upholding regulatory and cGMP standards. The ideal candidate will have extensive experience in analytical testing, method validation, and laboratory operations, along with a proactive approach to continuous improvement and compliance.

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

Qualifications

• Advanced degree (PhD, or equivalent) in Biology, Biochemistry, Analytical Chemistry, or a related field.
• Minimum of 5 years of experience in Quality Control within preferably a GMP-regulated biopharmaceutical or cell therapy environment or Academia.
• Strong expertise in analytical techniques such as flow cytometry, PCR, ELISA, HPLC, and microbiological testing.
• Proven leadership experience, with the ability to manage and develop high-performing teams.
• Deep understanding of regulatory requirements (cGMP, TITCK, EMA, ICH) and industry best practices for QC.
• Excellent problem-solving skills, attention to detail, and a commitment to continuous improvement.

Key Responsibilities

• Lead and manage the Quality Control department, ensuring all testing activities meet regulatory, company, and cGMP standards.
• Oversee analytical, microbiological, and raw material testing to ensure product safety, efficacy, and consistency.
• Drive method validation, transfer, and optimization to support robust and reliable analytical processes.
• Collaborate with manufacturing, quality assurance, and regulatory teams to maintain product quality throughout the lifecycle.
• Ensure compliance with CGMP, TITCK, EMA, and other regulatory requirements through rigorous documentation, data integrity, and audit readiness.
• Manage laboratory operations, including equipment qualification, personnel training, and process improvements.
• Implement and oversee stability studies, environmental monitoring, and trending analysis to detect and prevent potential quality issues.
• Lead investigations and corrective actions for out-of-specification (OOS) results, deviations, and other QC-related issues.
• Stay current with industry advancements and regulatory changes to ensure the QC function remains best-in-class.

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