GMP Compliance Manager

Canon Business Process Services; Rhode Island; On-site; USD 90,000 - 120,000; Full time

Job summary

Canon Business Process Services seeks a Compliance Manager to oversee QA, regulatory compliance, and training for temporary labor at client GMP warehouses in Rhode Island. Ensure adherence to FDA/cGMP, OSHA, and state labor laws; lead audits and CAPA efforts.

Role requires 3–5+ years in QA/compliance within regulated environments and a strong grasp of GDP and data integrity, with WMS familiarity for warehouse operations.

Qualifications

• Bachelor’s degree in Supply Chain, Business, or Quality Management or equivalent experience.
• 3–5+ years in QA, GMP, or Compliance role within pharma/regulated supply chain.
• Solid understanding of cGMP and GDP.
• Experience with warehouse operations and audits.

Responsibilities

• Establish, audit, and maintain vendor compliance programs aligned with client quality agreements.
• Lead training on data integrity, hygiene/gowning, GDP, and safety for placed workers.
• Act as primary liaison during client quality audits and FDA/OSHA inspections.
• Conduct on-site audits at RI client warehouses to verify GMP adherence.
• Oversee CAPA investigations related to vendor deviations or safety incidents.
• Maintain audit-ready personnel records including training, background checks, and clearances.
• Collaborate with QA teams to align vendor SOPs with facility requirements.
• Report compliance metrics to leadership and clients.
• Ensure vendor practices comply with RI DLT regs, OSHA standards, and local laws.

Skills

Quality assurance

Regulatory compliance

Training & SOP adherence

Data integrity

GMP knowledge

GDP knowledge

Auditing

Education

Bachelor's degree

Tools

Warehouse Management Systems

Job description

The Compliance Manager oversees all quality assurance, regulatory compliance, and training protocols for temporary and contract labor supplied to client GMP warehouse facilities. This role ensures that all deployed personnel strictly adhere to client SOPs, FDA/cGMP standards, OSHA regulations, and Rhode Island state labor requirements to prevent cross-contamination, product hold, or regulatory non-compliance.

Key Responsibilities

• Establish, maintain, and audit vendor-side compliance programs matching client quality agreements.
• Ensure all supplied workers complete required Data Integrity, Hygiene/Gowning, Good Documentation Practices (GDP), and warehouse safety training prior to site placement.
• Serve as the primary point of contact during client quality audits or regulatory (FDA/OSHA) inspections involving supplied labor.
• Perform regular on-site audits at RI client warehouse facilities to monitor worker adherence to GMP standards.
• Oversee Corrective and Preventive Action (CAPA) investigations for vendor-related deviations, non-conformances, or safety incidents.
• Maintain audit-ready personnel records, including training logs, background checks, drug screenings, and health clearances.
• Collaborate with client Quality Assurance (QA) teams to align vendor SOPs with facility-specific requirements.
• Track and report key compliance metrics (training completion rates, deviation counts, safety incidents) to leadership and clients.
• Ensure vendor workforce practices comply with Rhode Island Department of Labor and Training (DLT) regulations, OSHA standards, and local employment laws.

Qualifications & Requirements

• Education: Bachelor’s degree in Supply Chain, Business, or Quality Management (or equivalent experience).
• Experience: 3–5+ years in a Quality Assurance, GMP, or Compliance role within a pharmaceutical, medical device, or regulated supply chain environment.
• Deep understanding of cGMP regulations and Good Documentation Practices (GDP).
• Familiarity with warehouse management systems (WMS)