About the role
Mentor Technical Group (MTG) is seeking an experienced GxP Auditor to support pharmaceutical, biotechnology, medical device, and other regulated Life Sciences clients across the United States.
The GxP Auditor will plan, execute, document, and follow up on audits and compliance assessments to evaluate adherence to applicable regulatory requirements, industry standards, client procedures, and Quality Management Systems (QMS).
The role requires strong knowledge of GMP regulations, Quality Systems, audit methodologies, and regulatory expectations, as well as the ability to independently identify compliance gaps, assess risk, communicate findings, and provide practical recommendations for remediation.
Key Responsibilities
* Plan, prepare, conduct, and document GxP audits and compliance assessments at client and supplier facilities.
* Perform audits of manufacturing operations, laboratories, warehouses, utilities, engineering systems, computerized systems, and other GxP-regulated activities, as applicable.
* Conduct internal audits, supplier/vendor audits, third-party audits, mock regulatory inspections, and compliance gap assessments.
* Evaluate compliance with applicable FDA regulations, 21 CFR Parts 210 and 211, 21 CFR Part 11, and relevant ICH guidance and industry standards.
* Review Quality Management System elements including:
* * Deviations and investigations
* * CAPA
* * Change Control
* * Document Control
* * Training
* * Data Integrity
* * Validation and Qualification
* * Computerized Systems
* * Supplier Quality
* * Complaints and Quality Events
* * Annual Product Reviews / Product Quality Reviews
* Evaluate the effectiveness and maturity of client Quality Systems and identify potential regulatory and compliance risks.
* Conduct interviews with SMEs, Quality personnel, management, and operational staff during audits.
* Review procedures, records, protocols, reports, batch documentation, validation documentation, and other controlled records.
* Clearly document audit observations and classify findings based on risk, regulatory impact, and established client procedures.
* Prepare clear, concise, and defensible audit reports.
* Present audit findings to client management and relevant stakeholders during closing meetings.
* Review client responses and CAPA plans for adequacy and effectiveness.
* Support FDA inspection readiness and remediation programs, including mock inspections and regulatory gap assessments.
* Provide compliance guidance and recommendations while maintaining auditor independence and objectivity.
* Maintain awareness of changes in FDA regulations, guidance documents, enforcement trends, and industry best practices.
* Support MTG business development and technical teams by providing GxP auditing and regulatory compliance expertise when required.
Minimum Qualifications
* Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, Biology, or a related technical/scientific discipline.
* Minimum 5 years of experience in a GxP-regulated Life Sciences environment.
* Minimum 3 years of direct auditing, Quality Assurance, compliance, or regulatory experience.
* Demonstrated knowledge of cGMP requirements and FDA-regulated Quality Systems.
* Experience conducting or supporting internal, supplier, or regulatory compliance audits.
* Strong understanding of Quality Systems, risk management, investigations, CAPA, change control, and data integrity.
* Strong technical writing skills and experience preparing formal audit reports.
* Excellent verbal communication and interviewing skills.
* Ability to independently manage audit activities and interact effectively with client management and technical SMEs.
* Ability and willingness to travel throughout the United States based on project requirements.
Preferred Qualifications
* Lead Auditor certification or recognized auditor training.
* ASQ Certified Quality Auditor (CQA) or equivalent certification.
* Experience supporting FDA inspections, Warning Letter remediation, Consent Decree remediation, or major compliance improvement programs.
* Knowledge of ICH Q7, Q9, Q10, ISO 13485, 21 CFR Part 820, EU GMP, Annex 1, Annex 11, or other applicable international standards.
* Experience auditing pharmaceutical manufacturing, biotechnology, sterile manufacturing, laboratories, computerized systems, engineering, or validation activities.
* Experience with CSV/CSA, Data Integrity, ALCOA+, and 21 CFR Part 11.
* Previous consulting experience within the Life Sciences industry.
Core Competencies
* GxP Regulatory Compliance
* Audit Planning and Execution
* Quality Systems Assessment
* Risk-Based Decision Making
* Root Cause and CAPA Evaluation
* Data Integrity
* Technical Documentation
* Regulatory Inspection Readiness
* Client Communication
* Critical Thinking and Problem Solving
* Professional Judgment and Independence