GMP Compliance Lead — Pharma Operations

CSI INTERNATIONAL; Harvard (MA); On-site; USD 72,000 - 88,000; Full time

Job summary

CSI International, Inc. in Devens, MA is seeking a GMP Compliance Manager to oversee cleaning operations within a regulated pharmaceutical manufacturing environment, ensuring conformity with cGMP, GDP, and company procedures.

The role acts as a liaison between operations and quality to sustain inspection readiness and continuous improvement. Requirements include a related degree and at least two years in GMP settings, plus experience with document control and audits.

Qualifications

• Associate's or Bachelor's degree in a related field; equivalent experience.
• Minimum of 2 years of experience in a GMP-regulated environment.
• Knowledge of cGMP, 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.
• Ability to work within a regulated pharmaceutical manufacturing environment.
• Authorized to Work in the US – We Use Everify.

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.

Skills

Regulatory compliance

GMP

Documentation management

CAPA / root cause analysis

Audits / inspections

Communication skills

Education

Associate's or Bachelor's degree in a related field

Tools

Veeva

MasterControl

TrackWise

Job description

CSI International, Inc. in Devens, MA is seeking a GMP Compliance Manager to oversee cleaning operations within a regulated pharmaceutical manufacturing environment, ensuring conformity with cGMP, GDP, and company procedures.

The role acts as a liaison between operations and quality to sustain inspection readiness and continuous improvement. Requirements include a related degree and at least two years in GMP settings, plus experience with document control and audits.