Supervisor Manufacturing Operation and Compliance

Sun Pharmaceutical Industries Ltd•Billerica, MA

60d

About The Position

The Supervisor, Manufacturing Operations & Compliance is responsible for supervising compliance and operational activities within the manufacturing organization to ensure adherence to internal procedures, regulatory requirements, and quality standards. This role provides day-to-day leadership to manufacturing support personnel and serves as a key liaison between Manufacturing, Quality, Engineering, Training, Scheduling, and other cross-functional teams. The Supervisor oversees training compliance, investigations, CAPAs, change controls, deviations, and manufacturing readiness activities while driving continuous improvement initiatives. This position is responsible for ensuring compliant manufacturing operations, supporting personnel development, and fostering a culture of quality, accountability, and operational excellence.

Requirements

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.
Minimum 8 years or more of related experience supporting Manufacturing or Quality Departments

Nice To Haves

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.
Familiarity with electronic Quality Management Systems (Track Wise, EDMS, Master Control).

Responsibilities

Coordinate with cross-functional departments including Manufacturing, Quality Assurance, Engineering, Plant Services, Scheduling, Procurement, Materials, Management, Warehouse and Training to support compliant manufacturing operations.
Act as a compliance liaison for manufacturing activities, ensuring timely communication and issue resolution.
Support manufacturing readiness for audits, inspections, and internal reviews.
Coordinate manufacturing training activities in alignment with production schedules.
Track, monitor, and report training metrics to ensure personnel are qualified and current on required training.
Follow up on overdue or missing training and support remediation efforts.
Lead the initiation, tracking, and closure of Corrective and Preventive Actions (CAPAs) related to manufacturing.
Ensure CAPAs are appropriately documented, investigated, and implemented in accordance with quality system requirements.
Monitor CAPA effectiveness and support trending and reporting activities.
Lead change control activities impacting manufacturing processes, equipment, documentation, and materials.
Ensure change controls are properly assessed, documented, approved, and implemented.
Coordinate with stakeholders to ensure training and documentation updates are completed as part of change implementation.
Lead documentation, tracking, and investigation of manufacturing deviations and Unplanned Deviations (UPDs).
Ensure deviations are escalated, assessed, and resolved in a timely and compliant manner.
Assist with root cause analysis and support alignment with CAPAs when required.
Maintain accurate and compliant records within quality management systems.
Creation, review, and updates of manufacturing-related quality documentation.
Track compliance metrics and support periodic reporting to management.
Support new equipment qualification activities, including protocol execution and documentation, to ensure readiness for production or ILP use.
Update and maintain MBR (Master Batch Records) for both Production and ILP to reflect process changes and ensure effective, compliant use of equipment
Ensure compliance with cleanroom requirements, including adherence to gowning, environmental controls, and regulatory standards.
Coordinate and provide cleanroom-related training to employees working in controlled environments; maintain training records as per compliance requirements.
Review artworks, labels, and packaging components for accuracy, compliance, and alignment with approved specifications.
Works under direct supervision and follows clearly described process and procedures
Able to assist on the Production floor if required
Able to multi task and prioritize responsibilities