Supervisor Manufacturing Operation and Compliance

Sun Pharmaceutical Industries; Billerica (MA); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Sun Pharmaceutical Industries in the United States is seeking a Supervisor, Manufacturing Operations & Compliance to lead day-to-day manufacturing compliance activities, oversee training, CAPAs, deviations, change controls, and support readiness for audits.

This role partners with Manufacturing, Quality, Engineering, Training, Scheduling and other cross-functional teams to ensure adherence to procedures and quality standards.

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.
• 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.

Responsabilités

• 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 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 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

Connaissances

GMP knowledge

Quality systems

Regulatory requirements

Organizational skills

Coordination skills

Documentation systems

Data tracking tools

Formation

High School Diploma

B.S. in related field preferred or equivalent experience

Outils

TrackWise

EDMS

MasterControl

Description du poste

Job Summary

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.

Area Of Responsibility

Key Responsibilities include:

• 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

Work Conditions

• Office
• Lab
• Controlled 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.

Travel Estimate

Up to 0 %

Education and Job Qualification

• High School Diploma required; B.S. in related field preferred or equivalent experience

Experience

• Minimum 8 years or more of related experience supporting Manufacturing or Quality Departments
• Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Familiarity with electronic Quality Management Systems (Track Wise, EDMS, Master Control).
• Experience tracking training compliance metrics.
• Knowledge of root cause analysis tools and continuous improvement practices.