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Manager, Quality Assurance Operations

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first 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

Position Description:                 

This can be a remote role or hybrid role onsite in our Philadelphia, PA office.

Reporting to the Director, Quality Assurance Operations, the Manager, Quality Assurance Operations serves as a key member of the GxP Quality and Compliance team. This individual supports the implementation, execution, and continuous improvement of Cabaletta Bio's quality and compliance program, ensuring alignment with applicable regulations, industry standards, and internal SOPs and policies. The Manager is responsible for operationalizing quality system elements and providing QA oversight across the product lifecycle, including chain of custody, manufacturing, quality investigations, auditing, change control, CAPA, and raw material, intermediate, inprocess, and final product release. The role also plays a central part in internal and external BLA inspection readiness activities, including coordination with CDMOs.

Responsibilities

• Provide Quality oversight of external partners across the supply chain-including CDMOs, and cryopreservation sites-serving as the primary QA point of contact.
• Lead batch disposition activities to ensure timely, compliant, and rightfirsttime product release.
• Review and approve master batch records, QC test methods, validation protocols/reports, specifications, and associated documentation.
• Author, review, and revise SOPs and controlled documents as needed.
• Initiate, review, and approve investigations, root cause analyses, risk assessments, change controls, and CAPAs.
• Participate as a crossfunctional team member in process validation, analytical validation, technology transfer, and manufacturing readiness activities.
• Collaborate with CMC and GxP functional groups to provide QA guidance and support across development and manufacturing operations.
• Support internal and external audit programs, training initiatives, and inspection readiness activities.
• Develop, track, and report Quality metrics and KPIs for both internal processes and external partners to drive continuous improvement and ensure accountability.
• Work independently while fostering strong, collaborative relationships across internal teams and external partners.
• Champion a culture of quality, transparency and continuous improvement.
• Other related duties, as assigned.

Qualifications

• Bachelor's degree required, preferably in biomedical sciences, regulatory affairs, clinical research, nursing, or related health sciences.
• Cell and gene therapy experience required; autologous cell therapy experience strongly preferred.
• Minimum of 5+ years of relevant experience in Quality Assurance, Quality Operations, Quality Compliance and GMP manufacturing. 
• Minimum of 3 years providing Quality oversight of CDMOs within a GMP manufacturing environment or global pharmaceutical setting.
• Extensive knowledge of GMP, GCP, ICH guidelines, and FDA biologics regulations.
• Knowledge of federal research regulations and guidance, including 21 CFR Parts 11, 50, 54, 56, 312, 812; 45 CFR 46; ICH GxP guidance; and relevant EU/UK regulations.
• Demonstrated proficiency with electronic Quality Management Systems (eQMS).
• Excellent writing and presentation skills, with the ability to clearly interpret and communicate regulatory and compliance requirements.
• Strong interpersonal, communication, and leadership skills with the ability to influence and build effective professional relationships.
• Attention to detail and the ability to provide clear, pragmatic, riskbased QA guidance.
• Highly organized, selfdirected, and committed to continuous professional development.
• Thrive in a dynamic, fast-paced environment with evolving priorities.
• Experience supporting programs transitioning from earlyphase to latephase and commercial readiness is desirable.

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.

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