Associate Director, GLP/GCP Quality Audits and Compliance

About the position The Associate Director, GLP/GCP Quality Audits and Compliance plays a critical role in protecting data integrity and regulatory readiness across the company’s nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of internal and external GLP/GCP audits, ensuring compliance with U.S. and international regulations while driving continuous improvement in quality systems. As a trusted quality partner, this role provides expert guidance on GLP/GCP compliance, supports regulatory inspections, and works closely with internal teams and Contract Service Providers (CSPs) to maintain inspection-ready operations. The ideal candidate brings strong audit leadership, sound regulatory judgment, and the confidence to influence quality practices across the organization.

Responsibilities

• Plan, schedule, coordinate, and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs) in accordance with company standards and global regulatory requirements
• 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 (e.g., laboratory leadership, study directors, regulatory affairs, CSPs) 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
• Other duties as assigned

Requirements

• Bachelor’s degree in Life Sciences or a related scientific/technical discipline. An equivalent combination of education and applicable job experience may be considered
• Targeting 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%)

Nice-to-haves

• Society for Quality Assurance (SQA), American Society for Quality (ASQ) or ECA academy certification, and/or European Lead Auditor experience is a plus

Benefits

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance

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