Senior Principal GMP Compliance Auditor

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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