Supervisor Manufacturing Operation and Compliance

Key Responsibilities include: Collaborate with cross-functional departments including Manufacturing, ILP, Quality Assurance, Engineering, Plant Services, Scheduling, Procurement, Materials Management, Warehouse, and Training to support compliant and efficient manufacturing operations. Serve as the primary compliance liaison for manufacturing and ILP activities, facilitating timely communication, issue resolution, and adherence to quality system requirements. Coordinate manufacturing readiness activities for regulatory audits, customer inspections, and internal quality reviews. Manage training programs for Manufacturing and ILP personnel, ensuring qualification status, training compliance, and alignment with production schedules. Monitor training metrics, track overdue requirements, and support remediation efforts to maintain workforce qualification and regulatory compliance. Lead and support the initiation, tracking, investigation, and closure of Corrective and Preventive Actions (CAPAs), ensuring effective implementation and sustainability of corrective measures. Support Temporary Change Controls and Unplanned Deviation (UPD) investigations, including root cause analysis, risk assessment, and alignment with CAPA actions. Coordinate change control activities impacting manufacturing processes, equipment, materials, and documentation, ensuring timely assessment, approval, implementation, and training completion. Maintain accurate records within electronic quality management systems and support the creation, review, and revision of manufacturing quality documentation. Track and report key compliance and operational metrics to management, providing visibility into training, CAPA, deviation, and quality system performance. Support equipment qualification activities through protocol execution, documentation review, and production readiness assessments. Update, review and maintain Master Batch Records (MBRs) for Production and ILP operations to ensure compliance with current processes, equipment, and regulatory requirements. Ensure compliance with cleanroom standards, environmental controls, gowning requirements, and GMP regulations; provide cleanroom training and maintain associated records. Review and approve artwork, labels, and packaging components within the Artwork Management System (AMS) to ensure accuracy, compliance, and alignment with approved specifications. Perform On-the-Job Training (OJT) as a PAC Trainer, mentoring and qualifying Manufacturing and ILP personnel. Serve as backup to the Manufacturing & ILP Supervisor, supporting daily operations, personnel coordination, and departmental objectives. Demonstrate strong organizational, communication, and leadership skills with the ability to effectively manage multiple priorities in a fast-paced GMP manufacturing environment. Additional responsibilities as assigned Work Conditions: OfficeLabControlled areas

Required Qualifications: Working knowledge of GMP, quality systems, and regulatory requirements. Experience supporting CAPAs, change controls, and deviation management. Strong organizational and coordination skills with the ability to manage multiple priorities. Proficient in documentation systems and basic data tracking/reporting tools. Preferred

Qualifications: Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments. Familiarity with electronic Quality Management Systems. Experience tracking training compliance metrics. Knowledge of root cause analysis tools and continuous improvement practices.