GxP Quality Auditor Lead – Associate Director

Cabaletta Bio; Philadelphia (Philadelphia County); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health and retirement

PTO

Stock option plans

Job summary

Cabaletta Bio is seeking an Associate Director, GxP Auditor to join the Quality and Compliance team in a role focused on planning, conducting, and leading quality audits across external CDMOs, clinical sites, and internal operations.

The incumbent will serve as an SME for GxP auditing, drive the global audit strategy, and oversee CAPA design and implementation to strengthen processes and controls while ensuring regulatory compliance.

Qualifications

• Minimum bachelor's degree in any scientific discipline.
• 5–7 years of biopharmaceutical experience with at least 3 years of GxP auditing in a regulated environment.
• Excellent knowledge of GxP regulatory requirements.
• Experience using electronic Quality Management Systems.
• Auditor certification preferred.
• Ability to manage multiple projects in a fast-paced environment.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Detail oriented and organized in handling documents; strong prioritization skills.

Responsibilities

• Function as Quality/GxP auditor for external CDMOs, clinical sites, and internal labs.
• Implement global audit strategy aligned with regulatory requirements.
• Conduct audits across departments and functional areas.
• Perform risk assessments and develop audit plans.
• Review internal controls and recommend improvements.
• Collaborate with finance, operations, compliance, and legal to close findings.
• Lead investigations into fraud or non-compliance and propose actions.
• Prepare audit reports with findings and action plans.
• Maintain and improve CAPA processes.
• Provide training and coaching on audit practices.

Skills

Auditing

GxP

Project management

Detail-oriented

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline

Tools

eQMS (electronic Quality Management System)

Job description

Cabaletta Bio is seeking an Associate Director, GxP Auditor to join the Quality and Compliance team in a role focused on planning, conducting, and leading quality audits across external CDMOs, clinical sites, and internal operations.

The incumbent will serve as an SME for GxP auditing, drive the global audit strategy, and oversee CAPA design and implementation to strengthen processes and controls while ensuring regulatory compliance.