Associate Director, GxP Quality Auditor

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA™ platform encompasses two complementary strategies aimed at advancing the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases.

About the role

Reporting to the Audits Director, the Associate Director, GxP Auditor is an integral member of the Quality and Compliance team. This individual will plan and conduct scheduled quality audits on behalf of Cabaletta, act as a Subject Matter Expert (SME) for GxP auditing and quality projects, and support the implementation and management of the Quality Management Auditing system. The role involves independently managing quality/GxP auditing deliverables across the organization.

Responsibilities

• Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
• Implement the global audit strategy, aligning with organizational goals and regulatory requirements.
• Perform audits across various departments and functional areas.
• Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
• Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.
• Collaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved.
• Stay up to date with industry developments, regulatory changes, and emerging risks to anticipate potential impact on the organization.
• Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues.
• Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.
• Foster a culture of compliance and ethical behavior throughout the organization, providing training and guidance to employees on audit-related matters.
• Lead, conduct, and document investigations relating to audit findings noted internally.
• Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings.
• Offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation.
• Monitor the implementation of associated corrective and preventative actions for both internal and external observations through collaboration, teamwork, and influence.
• Coordinate and deliver audit logistics and deliverables, executing audits (remote or onsite) based on experience and Cabaletta requirements.
• Ensure audits are performed within budget and according to plan.
• Facilitate post-audit debriefs with internal stakeholders within defined timeframes, ensuring clear communication of audit findings.
• Produce draft and final versions of audit plans, reports, and summaries within defined timeframes and in accordance with internal policies/procedures.
• Promote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services.
• Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.
• Maintain a comprehensive understanding of regulatory requirements and ICH (International Council for Harmonization) guidance.
• Ensure audit practices and procedures comply with all applicable internal and external policies, procedures, and industry best practices.
• Develop/optimize new and existing processes to maintain and improve quality/results within the audit function.
• Provide coaching and/or training to Cabaletta peers on quality-related matters and audit performance.
• Administer both paper and electronic systems used to manage the supplier qualification processes within Cabaletta Bio.
• Prepare both internal and external audit plans and schedules with input from the Quality team.
• Present associated quality metrics to the Quality team.
• Perform other administrative/managerial duties as required.

Qualifications

• Minimum bachelor’s degree in any scientific discipline.
• A minimum of 5-7 years of biopharmaceutical experience, including at least 3 years of GxP auditing in a regulated environment, with cell and gene therapy (CGT) preferred.
• 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.
• Ability to understand when issues require escalation to Senior Quality Management.
• Detail-oriented with precision and organization in handling documents.
• Solid organizational skills with the ability to prioritize multiple tasks.

Benefits

• Competitive benefits package.
• Paid time off (PTO).
• Stock option plans.