GMP Compliance Manager; Devens, MA)

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Full Time Manager Harvard, MA, US

4 days ago Requisition

Salary: $80,000.00 Annually

Who We Are

CSI International Inc, founded in 1989, provides integrated building services to clients in real estate, property management, pharmaceuticals, telecommunications, higher education, manufacturing, and insurance. Throughout CSI International Inc.’s constant growth and evolution, our primary goal – exceeding our clients’ expectations – has remained unchanged. Because of this, we enjoy an incomparable reputation for cost-effective solutions with responsive services with uncompromising quality.

What You Will Be Doing

The GMP Compliance Coordinator is responsible for supporting the quality, compliance, and documentation programs associated with GMP cleaning operations within a regulated pharmaceutical manufacturing environment. This position ensures that cleaning activities, employee training, documentation practices, and quality systems comply with current Good Manufacturing Practices (cGMP), site procedures, and client requirements. The GMP Compliance Coordinator serves as a key liaison between operations and quality stakeholders, helping maintain inspection readiness, regulatory compliance, and continuous improvement initiatives.

This position is located in Devens, MA
.

GMP Compliance Manager Duties and Responsibilities

• Monitor GMP cleaning operations to ensure compliance with cGMP regulations, site procedures, and client quality standards.
• Identify, document, and assist in resolving compliance issues, deviations, non-conformances, and quality events.
• Support internal audits, client audits, and regulatory inspections by preparing documentation, coordinating records, and responding to information requests.
• Conduct routine inspections and compliance reviews to verify adherence to established cleaning and quality requirements.
• Manage GMP cleaning documentation, including logbooks, training records, and controlled documents.
• Review records for accuracy, completeness, and compliance with GDP and data integrity standards.
• Maintain document control systems and coordinate document revisions and change-control activities.
• 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.

GMP Compliance Manager 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, Master Control, or Track Wise preferred.
• Strong organizational, analytical, and communication skills.
• Proficiency in Microsoft Office applications.
• Ability to work within a regulated pharmaceutical manufacturing environment.
• Authorized to Work in the US – We Use Everify.

CSI International, Inc. is committed to fostering, cultivating, and preserving a culture of diversity and inclusion. We provide equal employment opportunities (EEO) to all employees and applicants for employment…