Associate Director, GxP Quality Auditor
Cabaletta Bio
August 06, 2026
Remote
United States
Operations
Associate Director, GxP Quality Auditor (Remote)
Responsibilities:
- Plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal lab operations.
- Implement global audit strategy aligned to organizational goals and regulatory requirements.
- Perform audits across departments; conduct risk assessments; review internal controls and recommend improvements.
- Collaborate cross-functionally (finance, operations, compliance, legal) to resolve audit findings.
- Stay current on industry/regulatory changes and emerging risks.
- Investigate fraud/unethical practices/non-compliance; lead/document internal investigations.
- Apply root cause analysis and interviewing techniques; develop CAPA recommendations; monitor corrective/preventive action implementation.
- Prepare audit plans, reports, summaries; facilitate post-audit debriefs; manage audit logistics and deliverables (remote/onsite); ensure audits follow budget/timeline.
- Provide audit-related training/coaching; administer supplier qualification systems (paper/electronic).
Preferred Qualifications:
- BS in a scientific discipline.
- 5–7 years biopharma experience; at least 3 years GxP auditing in regulated environments (CGT preferred).
- Excellent GxP regulatory knowledge (ICH guidance); experience with electronic Quality Management Systems.
- Auditor certification preferred.
- Strong organization/detail, ability to manage multiple projects, and work in a cross-functional matrix.
- Ability to escalate issues to Senior Quality Management.
Application:
- https://www.cabalettabio.com/join-our-crew
Responsibilities:
- Plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal lab operations.
- Implement global audit strategy aligned to organizational goals and regulatory requirements.
- Perform audits across departments; conduct risk assessments; review internal controls and recommend improvements.
- Collaborate cross-functionally (finance, operations, compliance, legal) to resolve audit findings.
- Stay current on industry/regulatory changes and emerging risks.
- Investigate fraud/unethical practices/non-compliance; lead/document internal investigations.
- Apply root cause analysis and interviewing techniques; develop CAPA recommendations; monitor corrective/preventive action implementation.
- Prepare audit plans, reports, summaries; facilitate post-audit debriefs; manage audit logistics and deliverables (remote/onsite); ensure audits follow budget/timeline.
- Provide audit-related training/coaching; administer supplier qualification systems (paper/electronic).
Preferred Qualifications:
- BS in a scientific discipline.
- 5–7 years biopharma experience; at least 3 years GxP auditing in regulated environments (CGT preferred).
- Excellent GxP regulatory knowledge (ICH guidance); experience with electronic Quality Management Systems.
- Auditor certification preferred.
- Strong organization/detail, ability to manage multiple projects, and work in a cross-functional matrix.
- Ability to escalate issues to Senior Quality Management.
Application:
- https://www.cabalettabio.com/join-our-crew