Location: Cambridge, MA Salary: $95.00 USD Hourly – $125.00 USD Hourly Description:
Title: Principal GMP Compliance Auditor
Type: 6 Month Contract
Location: Remote with travel domestic and international
Seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical manufacturing sites, laboratories, suppliers, CMOs, and quality systems. This role serves as a subject matter expert in global regulatory compliance, inspection readiness, and quality system effectiveness, providing risk-based assessments and strategic compliance guidance.
Key Responsibilities:
Lead GMP audits of manufacturing facilities, laboratories, suppliers, CMOs, and service providers.
Assess compliance with FDA, EU GMP, ICH, PIC/S, and other applicable regulations.
Conduct on-site and remote audits, document reviews, interviews, and facility inspections.
Identify compliance risks, prepare audit reports, and evaluate CAPA effectiveness.
Audit QC laboratories, analytical testing processes, data integrity, computerized systems, and 21 CFR Part 11 compliance.
Evaluate drug substance, drug product, packaging, validation, contamination control, and supplier quality programs.
Assess quality systems including deviations, investigations, CAPA, change control, training, validation, documentation, and risk management.
Support inspection readiness, mock inspections, and regulatory compliance initiatives.
Mentor quality professionals and provide GMP guidance to cross-functional teams.
Present audit findings and compliance risks to senior leadership.
Required Qualifications: Bachelor’s degree in a scientific, engineering, or related field.
10 years of pharmaceutical, biotechnology, or regulated industry quality experience.
Extensive experience independently leading GMP audits.
Strong knowledge of FDA, EU GMP, ICH, and global regulatory requirements.
Experience supporting regulatory inspections, remediation efforts, and quality system assessments.
Excellent communication, technical writing, and stakeholder management skills.
Ability to travel extensively throughout the U.S. and internationally.
Preferred Qualifications: QC laboratory auditing experience.
Expertise in data integrity and computerized systems auditing.
Experience with drug substance and drug product manufacturing.
Supplier Quality and CMO auditing experience.
Inspection readiness and mock inspection leadership experience.
ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification.
Core Competencies: GMP Compliance Auditing
Regulatory Compliance & Risk Assessment
CAPA and Root Cause Analysis
Quality Systems Evaluation
Data Integrity & Computer Systems Compliance
Audit Planning, Execution & Reporting
Leadership & Mentoring
Executive Communication & Stakeholder Management
Travel Requirements: Must be based in the United States with access to a major airport.
Travel domestically to US site and internationally
Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.
