Senior Quality Specialist – GMP Cell & Gene Therapy

About the role

Esco Aster is seeking a Senior Quality Specialist to support GMP readiness and ongoing compliance for cell and gene therapy manufacturing. You will work in a cGMP environment, ensuring that operations, documentation, and quality systems meet global regulatory standards.

Key responsibilities

• Initiate, investigate, and close deviations; manage CAPA processes and conduct effectiveness checks.
• Review, assess, and manage change controls for materials, equipment, processes, and documentation.
• Perform thorough reviews of batch manufacturing records, critical logbooks, and related documentation.
• Provide real‑time QA support on the manufacturing floor during production, aseptic operations, and changeovers.

Required profile

• Strong leadership and communication abilities.
• Ability to stay focused under pressure and adapt proactively.
• Critical thinker with a systematic, meticulous approach.
• Self‑motivated curiosity about cell/gene therapy and emerging technologies.
• Commitment to safety, quality, compliance, and timely delivery.
• Experience working in cleanroom and GMP manufacturing settings, including full gowning/PPE.
• Willingness to work overtime during campaigns or urgent troubleshooting.

Required skills

• GMP
• cGMP
• CAPA management
• Change control
• Deviation investigation
• Batch record review
• Cleanroom operations

What we offer

• Opportunity to work on cutting‑edge cell and gene therapy projects.
• Exposure to emerging modalities supporting translational sciences.