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.
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