Assistant Manager - Quality As · Bengaluru

Immuneel Therapeutics is a pioneering clinical-stage cell and gene therapy company focused on delivering advanced cellular immunotherapies for cancer management in India.

Key Responsibilities

• Manage and maintain the Quality Management System (QMS) in accordance with current GMP guidelines and regulatory standards.
• Oversee documentation control including reviewing and approving Standard Operating Procedures (SOPs), batch manufacturing records, and protocols.
• Lead root cause investigations for deviations, non-conformances, and market complaints, ensuring effective CAPA implementation.
• Plan and execute internal quality audits and support preparations for external regulatory inspections and client audits.
• Coordinate with production and quality control teams to ensure complete compliance across bioprocessing workflows.
• Review equipment qualification, facility validation, and analytical method validation protocols and summary reports.
• Monitor change control processes and evaluate the potential impact on product quality and regulatory status.
• Drive quality risk management activities across clinical and manufacturing operations.
• Deliver quality compliance and GMP training programs for operational and technical personnel.
• Track and report key quality performance indicators (KPIs) to senior leadership to foster continuous improvement.