GMP Compliance Manager (Devens, MA)

What You Will Be Doing

• Support the quality, compliance, and documentation programs associated with GMP cleaning operations.
• Ensure cleaning activities, employee training, documentation practices, and quality systems comply with cGMP, site procedures, and client requirements.
• Serve as a key liaison between operations and quality stakeholders, maintaining inspection readiness, regulatory compliance, and continuous improvement initiatives.

GMP Compliance Manager Duties And Responsibilities

• Maintain document control systems and coordinate document revisions and change-control activities.
• Manage GMP cleaning documentation, including logbooks, training records, and controlled documents.
• Review records for accuracy, completeness, and compliance with GDP and data integrity standards.
• Conduct routine inspections and compliance reviews to verify adherence to established cleaning and quality requirements.
• Support internal audits, client audits, and regulatory inspections by preparing documentation, coordinating records, and responding to information requests.
• Administer training programs and maintain qualification records.
• Support root cause investigations and CAPA programs.
• Analyze quality and compliance data and identify process improvements.
• Prepare reports, compliance metrics, and KPI summaries.
• Participate in operational, quality, and cross-functional meetings.
• Serve as a point of contact for client quality representatives.

Requirements And Qualifications

• Associate's degree or Bachelor's degree in a related field; equivalent experience may be substituted.
• Minimum of 2 years of experience in a GMP-regulated environment.
• Working knowledge of cGMP regulations, GDP, and data integrity principles.
• Experience managing controlled documents, training records, compliance programs, or quality systems.
• Familiarity with deviation investigations, CAPA processes, and root cause analysis.
• Experience supporting audits or inspections preferred.
• Familiarity with eQMS platforms such as Veeva, MasterControl, or TrackWise preferred.
• Strong organizational, analytical, and communication skills.
• Proficiency in Microsoft Office applications.
• Able to work within a regulated pharmaceutical manufacturing environment.
• Authorized to Work in the US – We Use Everify.