Associate Director, GxP Quality Auditor

🕒 August 6

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 20%

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Cabaletta Bio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2017

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Cabaletta Bio is a clinical-stage biotechnology company developing engineered T cell therapies to treat autoimmune diseases. Using its CABA® (Cabaletta Approach to B cell Ablation) platform, the company is advancing rese-cel, a fully human CD19 CAR T cell candidate with a 4-1BB co-stimulatory domain, in multiple RESET™ Phase 1/2 trials for systemic lupus erythematosus, myositis, systemic sclerosis, generalized myasthenia gravis, and pemphigus vulgaris. Cabaletta aims to deliver deep, durable, potentially curative responses by transiently eliminating B cells to reset immune tolerance, and emphasizes patient-centered development and broad indication expansion across rheumatology, dermatology, and neurology.

📋 Description

• Plan and conduct scheduled quality audits for external CDMOs, clinical sites, and internal laboratory operations • Implement the global audit strategy in alignment with organizational goals and regulatory requirements • Perform audits across departments and functional areas • Conduct risk assessments and develop audit plans and procedures • Review internal controls and recommend improvements to mitigate risks and strengthen processes • Collaborate with finance, operations, compliance, legal, and other cross-functional teams to resolve audit findings • Investigate fraud, unethical practices, non-compliance, and internal audit findings • Prepare audit reports, findings, recommendations, action plans, plans, schedules, and summaries • Lead root cause analysis, interviewing, and investigation documentation • Recommend and monitor corrective and preventative actions through CAPA design and implementation • Coordinate audit logistics and deliverables, including remote or onsite audits • Ensure audits are completed within budget and according to plan • Facilitate post-audit debriefs and communicate findings to stakeholders • Promote continual improvement of Quality/GxP auditing services • Maintain understanding of regulatory requirements and ICH guidance • Develop and optimize audit processes and procedures • Provide coaching and training on quality-related matters and audit performance • Administer paper and electronic systems for supplier qualification processes • Present quality metrics to the Quality team • Perform other administrative and managerial duties as required

🎯 Requirements

• Minimum bachelor’s degree in any scientific discipline (listed under Preferred Qualifications) • 5–7 years of biopharmaceutical experience • Minimum 3 years of GxP auditing in a regulated quality environment, 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 recognize when issues require escalation to Senior Quality Management • Detail-oriented, precise, and organized document handling • Solid organizational skills and ability to prioritize multiple tasks • Understanding of ICH guidance and applicable internal, external, and industry-best-practice requirements • Ability to travel 50% of the time (application question) • Must be authorized to work in the United States; the posting asks whether future visa sponsorship will be required

🏖️ Benefits

• Competitive benefits • PTO • Stock option plans • Commitment to employee well-being and continuous growth • Great Place to Work-Certified company