GMP Compliance Manager (Devens, MA)

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

GMP Compliance Manager (Devens, MA)

Full Time Manager Harvard, MA, US

5 days ago Requisition ID: 11795

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, 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.

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 without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Our commitment extends beyond preventing discrimination and harassment; it’s about creating an environment where diverse backgrounds and perspectives are valued. We believe in the power of our people, the ideas they bring, and what we can accomplish together.

Consistent with the Americans with Disabilities Act (ADA), all state & federal requirements, it is the policy of CSI International, Inc. to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. CSI International, Inc. also provides reasonable accommodations as required under the Pregnant Workers Fairness Act (PWFA) for limitations related to pregnancy, childbirth, or related medical conditions. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact the Recruitment Team at 813-425-1985.