Senior Principal GMP Auditor - Inspections Lead (Remote)

Judge Group, Inc.; Cambridge (MA); Remote; USD 131.000 - 172.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

Zusammenfassung

Judge Group, Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical sites, laboratories, suppliers, CMOs, and quality systems.

This role focuses on regulatory compliance, inspection readiness, and quality-system effectiveness, providing risk-based assessments and strategic guidance. The position involves conducting on-site and remote audits, preparing detailed reports, and guiding cross-functional teams while traveling domestically and

Qualifikationen

• Bachelor’s degree in a scientific, engineering, or related field.
• 10 years of pharmaceutical, biotechnology, or regulated industry quality experience.
• Extensive experience leading GMP audits independently.
• Strong knowledge of FDA, EU GMP, ICH, and global regulatory requirements.
• Willingness to travel extensively throughout the U.S. and internationally.

Aufgaben

• 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.

Kenntnisse

GMP Auditing

Regulatory Knowledge

Audit Leadership

Data Integrity

Communication

Travel Flexibility

Stakeholder Management

Ausbildung

Bachelor’s degree in science/engineering

Jobbeschreibung

Judge Group, Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical sites, laboratories, suppliers, CMOs, and quality systems.

This role focuses on regulatory compliance, inspection readiness, and quality-system effectiveness, providing risk-based assessments and strategic guidance. The position involves conducting on-site and remote audits, preparing detailed reports, and guiding cross-functional teams while traveling domestically and