Senior Executive – In-Process Quality Assurance

Job Summary The Senior Executive – Cell & Gene Therapy (CGT) Manufacturing is responsible for executing and monitoring CGT production activities in compliance with cGMP/cGTP requirements. The role ensures aseptic process adherence, real-time documentation, deviation reporting, and shopfloor regulatory compliance. Key Responsibilities Execute CGT manufacturing processes as per approved SOPs and batch records. Perform line clearance and equipment readiness checks prior to batch initiation. Ensure that all production activities are performed in accordance with the approved Standard Operating Procedures (SOPs) and batch records. Conduct regular audits of the manufacturing area to ensure compliance with cGMP/cGTP requirements. Identify and report any deviations from SOPs or batch records to the Quality Assurance Manager. Develop and maintain a comprehensive understanding of CGT production processes, including cell culture, fermentation, and downstream processing. Collaborate with cross-functional teams to resolve manufacturing issues and implement process improvements. Provide training and guidance to manufacturing personnel on cGMP/cGTP requirements and SOPs. Maintain accurate records of all activities performed in the manufacturing area, including batch records, deviation reports, and audit findings. Develop and maintain a comprehensive understanding of CGT production processes, including cell culture, fermentation, and downstream processing. Collaborate with cross-functional teams to resolve manufacturing issues and implement process improvements. Provide training and guidance to manufacturing personnel on cGMP/cGTP requirements and SOPs. Maintain accurate records of all activities performed in the manufacturing area, including batch records, deviation reports, and audit findings. Key Requirements Bachelor's degree in a life science or related field. Minimum 5 years of experience in CGT manufacturing or quality assurance. Strong understanding of cGMP/cGTP regulations and guidelines. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment with multiple priorities. Strong attention to detail and ability to maintain accurate records. Certification as a Quality Assurance Professional (QAP) or equivalent is desirable.