Oversee all analytical testing activities to ensure compliance with cGMP, GLP, ANVISA RDC, and other applicable regulatory requirements, ensuring data integrity, accuracy, and traceability throughout all operations, maintaining the laboratory in a state of inspection readiness. - Ensure robust method transfer processes are in place and executed effectively, collaborating closely with R&D, manufacturing, and third-party contractors. - Drive the timely release of analytical results within schedules while maintaining stringent quality standards. - Manage the acquisition, qualification, calibration, and maintenance of all QC laboratory equipment and instrumentation. - Oversee the entire process for chemicals, reagents, and reference standards management, from procurement to disposal, ensuring supply chain integrity and compliance. - Establish and maintain robust quality systems within QC, including OOS/Deviation management, CAPA effectiveness, change control, and risk management. Provide strategic direction for complex method troubleshooting, OOS investigations and other quality related process. - Forecast and manage the departmental budget, including staffing, equipment, consumables, and external services. - Develop and implement the strategic vision and operational plans for the QC department, aligning with the company's overall business objectives and quality goals. - Actively participate in internal and external regulatory audits (e.g., ANVISA, client audits), providing expert responses and presenting laboratory data and processes. - Act as a primary point of contact and subject matter expert for all QC-related discussions during internal and external audits. Lead the preparation and response to audit findings, ensuring timely and effective CAPA implementation and closure. - Stay abreast of new and evolving pharmaceutical regulations and industry best practices, ensuring the QC department remains fully compliant. - Establish and monitor departmental Key Performance Indicators (KPIs) to drive efficiency, compliance, and quality improvements. - Oversee recruitment, training, performance management, and career development for all QC personnel. Ensure adequate staffing levels and competencies to meet operational demands and future growth. - Conduct performance reviews, provide constructive feedback, identify training needs, and support the professional development of team members. - Promote a strong safety, continuous improvement and proactive problem-solving culture within the laboratory, ensuring all team members adhere to EHS policies and procedures. - Collaborate effectively with other departments such as Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Supply Chain, and Project Management to ensure seamless operations and achieve company goals. - Participate in management review meetings, product development teams, and other cross- functional committees as required. Experience- 5 to 15 Years