Associate Director, GxP Quality Auditor

Position Title: Associate Director, GxP Quality Auditor

Location: Remote

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. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

About the Position:

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.
• 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:

(What to consider)

• What experience is necessary on Day 1?
• Required Education
• What skills cannot realistically be taught during onboarding?
• What qualifications are required due to compliance, regulatory, or business needs?
• If a candidate lacks this requirement, would they automatically be disqualified?

Preferred 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. 

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.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

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.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-REMOTE