Description

You will lead the planning, execution, and reporting of internal and external GLP/GCP audits to ensure compliance with U.S. and international regulations. This role involves protecting data integrity and regulatory readiness across the company's nonclinical and clinical portfolio while driving continuous improvement in quality systems. You'll serve as a GLP/GCP subject matter expert, providing guidance on compliance and supporting regulatory inspections.

Requirements

• Bachelor’s degree in Life Sciences or a related scientific/technical discipline
• 8+ years of progressively responsible experience within quality assurance (QA), including 5+ years directly responsible for GLP/GCP QA, with direct experience leading external and internal audits
• Extensive knowledge of guidelines and international regulations that affect the GLP/GCP QA programs
• Thorough knowledge of quality management best practices within the pharmaceutical, biopharmaceutical, or other regulated industries
• Demonstrated expertise in quality assurance activities and ICH, FDA, EU, and international GLP/GCP regulations as they apply to nonclinical and clinical studies
• Proven ability to interpret and apply GLP/GCP regulations, including U.S. and global requirements
• Hands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilities
• Strong capability to translate quality standards into practical implementation, assess compliance, and drive continuous process improvement
• Effective communicator able to present technical and regulatory information clearly across functions and to different stakeholder groups
• Ability to create alignment and shared understanding among peers and stakeholders, effectively coordinating resources and motivating teams to achieve quality objectives
• Demonstrated analytical, planning, and negotiation skills, with sound judgment in evaluating risk and compliance impact
• Collaborative approach with a proven ability to gain cooperation and influence outcomes without direct authority
• Willingness to travel domestically and internationally (approximately 25–30%)

Responsibilities

• Plan, schedule, coordinate, and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs)
• Own the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actions
• Prepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved
• Develop, review, and maintain GLP/GCP quality agreements, SOPs, and related quality documentation supporting nonclinical and clinical activities
• Maintain, manage, and continuously improve the internal GLP/GCP audit program, ensuring ongoing inspection readiness
• Compile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspections
• Serve as a GLP/GCP subject matter expert, partnering with internal and external stakeholders to ensure consistent regulatory compliance
• Support internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide impact, and ensure adherence to company policies, including Privacy/HIPAA and other applicable legal and regulatory requirements