Site Quality Head

Role Overview: As a Quality Assurance Manager in the Biotech/ Pharmaceutical API industry with experience in Microbial Fermentation (Classical), your main responsibility will be to ensure compliance with regulatory guidelines and expectations. You will be in charge of preparing, reviewing, and approving all procedures, identifying gaps, and updating them as necessary. Additionally, you will handle day-to-day changes, deviations, incidents, market complaints, and investigations in a timely manner. Key Responsibilities: - Develop and train second-line personnel by imparting knowledge to operating level staff and supervisors on risk and science-based decision-making. - Coordinate with various functions such as R&D, production, engineering, regulatory affairs, purchase, compliance, and marketing to establish a robust system that meets regulatory standards. - Conduct training sessions for technical staff to instill a culture of quality and compliance, ensuring adherence to training schedules. - Host audits by customers and regulatory authorities, actively participating in technical discussions with customers and suppliers to enhance overall customer satisfaction. - Provide regulatory and customer audit responses in collaboration with corporate quality, monitoring CAPA's for timely closures. - Lead investigations into quality issues, providing technical clarifications to the marketing team and customers promptly. - Identify infrastructural requirements, organize timely procurement to enhance the efficiency of quality functions. - Develop mechanisms for measuring productivity and achieving organizational QA&QC goals. - Respond promptly to all marketing requests and quality notifications, tracking and updating closures efficiently. - Prepare and review quality trends of products, respond to regulatory queries related to analytical validation, and ensure successful qualification and validations as per schedule. - Prepare and approve Annual Product Review in a timely manner. - Steer and participate in Quality Management reviews at different levels within the site and present findings to top management. Qualifications Required: - Preferably from the Biotech/ Pharmaceutical API industry with experience in Microbial Fermentation (Classical). - Strong understanding of regulatory guidelines and expectations. - Excellent communication and coordination skills to work across different functions effectively. - Ability to lead investigations, provide technical clarifications, and implement actions for continuous improvement. - Proven track record of successful quality management and compliance in a regulated environment.,