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Cabaletta Bio · 1 day ago

Audit Director, Quality & Compliance

Philadelphia, PA

Full-time

Hybrid

Director/Executive

10+ years exp

Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases. The Audit Director will lead the GxP audit program, ensuring compliance with global regulatory expectations and managing the audit team to maintain inspection readiness.

BiotechnologyHealth CareMedicalRoboticsTherapeutics

Responsibilities

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

Qualification

GxP audit experienceFDA regulations knowledgeLeadership experienceQuality Management SystemRegulatory inspections supportCertifications ASQCertifications RACAnalytical skillsOrganizational skillsCommunication skillsCollaboration skillsAdaptability