Compliance Lead

Role Summary

Compliance Lead based in Framingham, MA. Oversees the EM compliance department within Engineering and Maintenance, coordinating compliance efforts, investigations, CAPAs, and change controls to support manufacturing facilities and maintain cGMP standards.

Responsibilities

• Ensure safety of all EM areas and work practices in accordance with site Health, Safety and Environmental program.
• Recruit and manage staff to execute department functions; ensure effective utilization of resources through performance management and recognition practices.
• Provide leadership and direction to staff in alignment with cGMP requirements, department goals, and corporate quality standards.
• Partner with the Manufacturing Scheduler to ensure on-time closures of deviations that can impact shipment dates.
• Create and maintain tracking metrics for Deviation, CAPA, and CCRs to ensure visibility of open or overdue events.
• Ensure appropriate levels of trained resources are available to meet production schedules.
• Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams.
• Establish key performance indicators aligned with department goals and report applicable metrics.
• Escalate key risks and issues to manufacturing senior management and cross-functional support teams.
• Partner with Safety to ensure department compliance with Safety Program requirements (Health and Safety regulations and OSHA).
• Ensure EM documentation and records reflect practices and are aligned to cGMPs and corporate standards.
• Design and manage department training plans and ensure timely completion of investigations, deviations, and CAPAs.
• Implement continuous improvement initiatives and change controls as needed; utilize quality metrics to measure and improve team performance.
• Ensure timely review of quality deliverables and “right first time”; maintain inspection readiness of EM areas; approve department documentation changes; participate in regulator inspections.
• Identify opportunities to improve EM processes; drive cross-functional problem solving and continuous improvement projects to completion.

Qualifications

• Required: Bachelor’s degree in Engineering, Automation, Life Sciences, or related discipline (preferred). 5+ years of experience using Root Cause Analysis tools (5W2H, fishbone, DMAIC, GPS3) with consistent Right First Time performance; ability to perform Deviation Investigations; experience leading direct reports or teams in a cGXP/cGMP environment.
• Preferred: Extended experience in EM and/or pharmaceutical manufacturing; experience leading EM teams to maintain adherence to a demanding schedule; cross-functional collaboration with Quality, Manufacturing, Technical Support, Operations, and Validation; strong documentation practices; familiarity with Deviation Management Systems; experience in troubleshooting, investigation, root cause and risk analysis in a cGMP environment; experience implementing improvements to technical and business processes; prior management of leadership-responsible direct reports (supervisors/managers); ability to make tactical safety, process, and scheduling decisions.

Skills

• Root cause analysis and investigation management
• Deviation, CAPA, and change control processes
• cGMP/cGXP compliance and regulatory readiness
• Documentation control and batch documentation practices
• Cross-functional collaboration and leadership
• Quality metrics analysis and continuous improvement

Education

• Bachelor’s degree in Engineering, Automation, Life Sciences, or related discipline (preferred; combination of education and experience considered)

Additional Requirements

• Ability to gown and gain entry to manufacturing areas.
• Primarily day shift, with flexibility and accessibility to work with rotating shift(s).