Quality Operations ManagerThe Quality Operations Manager provides hands-on support for Manufacturing and Quality activities and directly manages daily Quality Operations functions. This position supports the Quality Systems within the Quality Assurance Unit by ensuring cGMP compliance for finished pharmaceuticals and Active Pharmaceutical Ingredients (API), actively partnering with Manufacturing, Quality Control, Validation, Metrology, and other cross-functional teams to resolve quality issues, drive investigations, support batch execution, and maintain inspection readiness.Job ResponsibilitiesManage the day-to-day priorities, workload, and performance of Quality Operations personnel, while remaining directly involved in shop-floor quality support, issue resolution, documentation review, and escalation of quality events.Manufacturing/Quality Assurance Liaisons (MQAs)Scientific/Quality Assurance Liaisons (SQAs)Metrology Manager and Calibration TechnicianQA Compliance AssociateLead and perform manufacturing investigations, including gathering data, interviewing personnel as needed, reviewing batch records and equipment records, documenting root cause, writing investigation reports, and driving timely corrective and preventive actions for:Incident ReportsProcess Deviation ReportsCustomer ComplaintsInternal Audit ResponsesInternal Process Observation ResponsesProvide hands-on Quality Operations support for Development Batches, API Synthesis, commercial manufacturing, and PPQ activities by coordinating documentation, participating in production readiness activities, resolving real-time quality questions, and ensuring required records are accurate and complete, including:MBR generation and/or revisionMaintenance of the Master Batch Record Revision TableLot number assignmentBPR issuance and reconciliationCross-functional coordination to plan, prepare, and execute development products and PPQ batchesPost-execution review of Batch Production RecordsPreparation of documentation for API product dispositionTracking and trending of Quality metricsProvide hands-on oversight of cGMP equipment by partnering with Metrology, Maintenance, Validation, and Manufacturing to ensure calibration status, equipment records, logbooks, and related quality documentation are complete and compliant.Support manufacturing of commercial products by providing on-the-floor quality guidance, reviewing executed documentation, assessing documentation discrepancies, and escalating quality or compliance concerns when appropriate.Support the Internal Audit Program by preparing audit responses, collecting objective evidence, assisting with CAPA implementation, and verifying completion of assigned actions.Performs other duties as assigned.Coach, train, and develop Quality Operations team members by reviewing work products, providing performance feedback, reinforcing cGMP expectations, and ensuring team members understand priorities, procedures, and documentation standards.Monitor open investigations, deviations, CAPAs, audit responses, batch record reviews, and equipment-related quality activities to ensure timely completion and appropriate escalation of overdue or high-risk items.Education RequirementsBachelor's Degree in a scientific discipline required and a minimum of seven (7) years of experience in pharmaceutical manufacturing, quality assurance, quality operations, or a related regulated industry Required.A minimum of two (2) years of supervisory, team lead, or people management experience Preferred.Experience RequirementsMust be able to read and write English, possess technical writing skills, perform mathematical calculations, write and follow scientific terminology and notation.Must be able to follow instructions, attend to details, multi-task, and handle multiple priorities without undue stress or errors.Must have computer skills including MS Outlook, and be proficient using MS Word and MS Excel.Must be able to sit and/or stand for extended periods of time,Must be able to climb stairs, must be able to lift and carry 25 lbs, and walk while carrying itemsMust be able to see very small print and tiny graduations.