Audit Director, Quality & Compliance

• Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
• Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
• Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
• Evaluate organizational risk and adjust audit scope and approach accordingly
• Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
• Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
• Support team succession planning and capability building as the audit function grows
• Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
• Oversee vendor and third-party audits to qualify and maintain GxP suppliers
• Ensure timely issuance of audit reports, management responses, and CAPA plans
• Track, trend, and monitor CAPA effectiveness and timely closure
• Partner with CMR, CMC, and Quality teams to drive enterprise-wide inspection readiness for FDA, EMA, and other regulatory agencies
• Identify systemic issues and organizational risks through audits and propose proactive mitigation strategies
• Serve as a subject matter expert during inspections, helping teams respond to regulatory requests and remediation activities
• Maintain and enhance audit-related SOPs, templates, and quality processes
• Provide regular updates to Chief Compliance Office and operational leadership team, governance committees as required
• Lead quality risk assessments and feed critical risks into the enterprise risk management framework
• Contribute to QMS improvements to support operational excellence and commercial readiness
• Partner with CMR, CMC, Manufacturing, Translational Sciences, IT, Regulatory, and Legal to ensure alignment on compliance expectations
• Serve as a trusted advisor on GxP compliance and risk
• Support training initiatives and lessons learned from audits

• Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
• 10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
• Demonstrated experience leading internal and external GxP audits
• Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
• Experience supervising or mentoring employees
• Strong analytical, organizational, and communication skills
• Ability to manage competing priorities in a fast-paced, rapidly growing company
• Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
• Experience preparing for and supporting regulatory inspections preferred
• Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred
• Experience with QMS systems preferred

• Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
• Experience preparing for and supporting regulatory inspections preferred
• Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred
• Experience with QMS systems preferred
• Leadership & Coaching: Ability to develop talent and build a high-performing audit function
• Risk-Based Thinking: Ability to evaluate and prioritize risks in a complex scientific environment
• Independence & Integrity: Demonstrates strong ethical judgment and objective decision-making
• Communication: Clear, concise communication tailored to all organizational levels, including executive leadership
• Collaboration: Works seamlessly across cross-functional teams
• Adaptability: Thrives in a dynamic environment shifting toward commercial readiness

health and retirement, PTO, and stock option plans