GMP Compliance Manager — Pharma Quality & Audits

ADP, Inc.; Harvard (MA); On-site; USD 72,000 - 88,000; Full time

Job summary

CSI International, Inc. is seeking a GMP Compliance Manager (Devens, MA) to oversee cleaning operations in a regulated pharmaceutical manufacturing environment. The role ensures compliance with cGMP, GDP, and client requirements, serving as a liaison between operations and quality teams.

Located in Devens, MA, the position focuses on maintaining inspection readiness, quality systems, and continuous improvement initiatives through documentation, training, and data analysis.

Qualifications

• Minimum of 2 years in a GMP-regulated environment.
• Familiarity with eQMS platforms such as Veeva, MasterControl, or TrackWise.
• Experience managing controlled documents, training records, and quality systems.
• Ability to identify deviations, CAPA, and perform root cause analysis.

Responsibilities

• Monitor GMP cleaning operations to ensure compliance with cGMP, GDP, and client standards.
• Support internal and client audits, and regulatory inspections with documentation.
• Maintain GMP cleaning documentation, logbooks, and training records.
• Administer training programs and maintain qualification records.
• Assist in root cause investigations and CAPA programs.
• Prepare reports and KPI summaries; participate in cross-functional meetings.

Skills

GMP regulations

cGMP

Data integrity

Audits

Training records

Communication skills

Microsoft Office

Education

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

Tools

Veeva

MasterControl

TrackWise

Job description

CSI International, Inc. is seeking a GMP Compliance Manager (Devens, MA) to oversee cleaning operations in a regulated pharmaceutical manufacturing environment. The role ensures compliance with cGMP, GDP, and client requirements, serving as a liaison between operations and quality teams.

Located in Devens, MA, the position focuses on maintaining inspection readiness, quality systems, and continuous improvement initiatives through documentation, training, and data analysis.