Associate Director, GxP Quality Auditor

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

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 Include

• 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.
• Will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation.
• For both internal and external observations monitor the implementation of associated corrective and preventative actions through collaboration, teamwork and influence.
• Coordinate and deliver audit logistics and deliverables. They will execute audits (remote or onsite) based on experience, Cabaletta requirements (as defined by policy/procedure).
• 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.
• Will work to ensure the 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.
• Will administer both paper and electronic systems used to manage the supplier qualification processes within Cabaletta Bio.
• With input from the Quality team, prepare both internal and external audit plans and schedules. Will present associated quality metrics to the Quality team.
• Performs other administrative/managerial duties as required.

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

• Health and retirement
• PTO
• Stock option plans

Equal Opportunity Employer

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.