Join Our Crew

Responsibilities Include

Audit Program Leadership

• 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.

Management & Supervision

• 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.

Audit Execution & Reporting

• 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.

Inspection Readiness

• 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.

Governance & Continuous Improvement

• 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.

Cross-Functional Collaboration

• 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.

Required Qualifications

• 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.

Preferred Skills

• 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.

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