[Hiring] Associate Director, GxP Quality Auditor @Cabaletta Bio

Role Description

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

Responsibilities

• Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
• Implementation of 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.
• Responsible for leading, conducting, and documenting 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 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 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 a minimum of 3 years of GxP auditing in a regulated environment focused on quality, with 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.
• Must be detail oriented; must be precise and organized in handling of documents.
• Solid organizational skills required; must be able to prioritize multiple tasks.

Benefits

• Competitive benefits.
• PTO.
• Stock option plans.

Company Description

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 which aim to advance 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.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.