Compliance Lead

Role Summary

Compliance Lead based in Framingham, MA, responsible for managing the compliance Engineering and Maintenance (EM) department, coordinating compliance efforts for the EM Department, and ensuring alignment with cGMP requirements and corporate quality standards. Oversees the EM team of engineers and specialists, supports manufacturing facilities, and monitors performance against department goals.

Responsibilities

• Management: Ensure safety of all EM areas, recruit and manage staff, provide leadership aligned with cGMP requirements, partner to ensure on-time closure of deviations affecting shipment dates, create and maintain tracking metrics for Deviation, CAPA, and CCRs, ensure adequate trained resources, identify and mitigate risks, establish and report KPIs, escalate risks as needed.
• Compliance/Training/Deviations: Ensure department compliance with Safety Program and OSHA requirements; maintain staff knowledge of processes and procedures; ensure EM documentation and records reflect practice and are aligned to cGMPs and corporate standards.
• Partners With EM Managers To Ensure The Following: Design and execute the department training plan, maintain accurate training materials, ensure timely completion of investigations, deviations, and CAPAs, implement continuous improvement initiatives and change controls, use quality metrics to measure and improve team performance.
• Partner With Quality To Ensure The Following: Timely review of quality deliverables and right-first-time outputs; ensure inspection readiness of EM areas; approve department documentation changes; participate in external regulator inspections.
• Continuous Improvement: Identify opportunities to improve EM processes, troubleshoot and resolve operational issues with cross-functional teams, drive continuous improvement projects to completion, ensure appropriate controls, approvals, and validation for departmental projects.

Qualifications

• Required: Bachelor‚Äôs degree in Engineering, Automation, Life Sciences, or related discipline (preferred); 5+ years using root cause analysis tools (5W2H, fishbone, DMAIC, GPS3) with consistent Right First Time performance and 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 on demanding schedules; cross-functional collaboration with Quality, Manufacturing, Technical Support, Operations, and Validation; strong documentation practices (batch records, SOPs, OJTs, controlled documents); familiarity with Deviation Management Systems; troubleshooting, investigation, root cause and risk analysis in a cGMP environment; leadership of improvements to technical and business processes; experience managing direct reports with leadership responsibilities; ability to make tactical safety, process, and scheduling decisions.

Additional Requirements

• Special Working Conditions: Ability to gown and gain entry to manufacturing areas; primarily day shift with flexibility for rotating shifts.