Our RESETTM clinical trials with rese-cel (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.

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Manager, Quality Assurance Operations

About the Position

This is a hybrid role requiring time 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, in process, and final product release. The role also plays a central part in internal and external BLA inspection readiness activities, including coordination with CDMOs.

Responsibilities Include

  • 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 right first time 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 cross functional 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.

Required 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, risk-based QA guidance.
  • Highly organized, self-directed, and committed to continuous professional development.
  • Ability to thrive in a dynamic, fast-paced environment with evolving priorities.
  • Experience supporting programs transitioning from early phase to late phase and commercial readiness is desirable.

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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and 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.