Job Title

Purpose: To lead Quality Control operations ensuring cGMP/cGLP compliance, data integrity, timely testing, and batch release while maintaining audit readiness. Key Responsibilities - Lead and manage all QC activities in accordance with approved SOPs and regulatory requirements. - Approve job descriptions, assign responsibilities, and develop QC team members through training. - Review and approve analytical documentation ensuring cGMP, cGLP, ALCOA++ compliance, and data integrity. - Prepare, review, and approve QMS activities including OOS, OOT, Deviations, Change Control, CAPA, and Incidents. - Ensure proper sample receipt, testing, review, approval/rejection, and timely batch release to meet SLAs and dispatch plans. - Plan and allocate resources for testing of RM, IP, Bulk, FG, Validation, Stability, and external lab samples. - Ensure specifications, STPs, worksheets, protocols, reports, and CoAs are current, controlled, and approved (LIMS/manual). - Ensure QC laboratory is maintained in an audit-ready condition at all times. - Oversee calibration, verification, AMC, and qualification of all QC instruments prior to use. - Ensure control and validity of standards, reagents, volumetric solutions, chemicals, and reference materials. - Coordinate with cross-functional teams, customers, and external laboratories for smooth operations and project transfers. - Prepare monthly QC performance reports and manage QC OPEX and CAPEX budgets. - Ensure safe, compliant, and environmentally responsible laboratory operations including gowning/de-gowning practices. Qualifications - Master's degree in Chemistry - 12+ years' relevant work experience in Quality Control USFDA approved manufacturing OSD facility