Compliance Lead - Right First Time - GMP

Role Summary

Compliance Lead - Right First Time - GMP

Location

Framingham, MA

Role Summary

Responsible for managing a compliance EM department supporting and coordinating Compliance efforts for the EM Department consisting of Engineers and specialists. Supports manufacturing facilities and manages staff performance against department’s operational goals.

Responsibilities

• Ensure safety of all EM areas and work practices in accordance with site Health, Safety and Environmental program.
• Recruits and manages staff to execute department functions; ensure effective utilization of resources through consistent performance management, and rewards and recognition practices in area of responsibility.
• Provides leadership, guidance, and direction to staff in alignment cGMP requirements, department goals and corporate quality standards.
• Partners 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 to open or overdue events.
• Ensures that appropriate levels of trained resources are available to meet production schedules.
• Proactively identifies, assesses, and mitigates operational and organizational risks, escalate key risks and issues to manufacturing senior management and cross-functional support teams.
• Establishes key performance indications in alignment with department goals, maintain and report applicable area or organizational metrics.
• Escalate key risks and issues to manufacturing senior management and cross-functional support teams

Qualifications

• Basic Qualifications: Bachelor’s degree in Engineering, Automation, Life Sciences, or related discipline - preferred. A combination of education and experience will be considered.
• 5+ years of experience using various Root Cause Analysis tools (5W2H, fishbone, DMAIC, GPS3) which achieves consistent RFT (Right First Time) performance and the ability to perform Deviation Investigations - required.
• Experience leading direct reports or teams in a cGXP/cGMP environment - required.
• Preferred Qualifications: Extended experience in EM and/or pharmaceutical manufacturing.
• Experience leading EM teams to maintain adherence to a demanding schedule.
• Experience working with cross-functional teams, including Quality, Manufacturing, Technical Support, Operations, and Validation.
• Strong documentation practices including batch production records, SOPs, OJTs, and other controlled documents.
• Familiarity with Deviation Management Systems.
• Experienced in troubleshooting, investigation, root cause and risk analysis in a cGMP environment.
• Experienced leading the implementation of improvements to technical and business processes.
• Experienced in managing direct reports who have leadership responsibilities (supervisors and managers).
• Experienced in making tactical decisions on safety, process, scheduling

Skills

• cGMP/cGXP compliance
• Root cause analysis
• Deviation and CAPA management
• Documentation control
• Leadership and people management
• Risk assessment and mitigation
• Cross-functional collaboration

Education

• Bachelor’s degree in Engineering, Automation, Life Sciences, or related discipline - preferred

Additional Requirements

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