Manager, GLP Compliance

Cabaletta Bio Inc.•Philadelphia, PA

9d•Remote

About The Position

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 [http://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® [https://www.greatplacetowork.com/certified-company/7024943]

Requirements

Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or a related scientific discipline.
Minimum of two (2) years of hands-on experience in biopharmaceutical operations, laboratory operations, technical operations, quality operations, or a related GxP environment.
Minimum of one (1) year of experience supporting Document Control within a GxP environment, including experience with controlled documents, electronic document management systems, and Trial Master File (TMF) documentation.
Working knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), ICH guidelines, and applicable FDA regulations.
Understanding of Quality Management Systems (QMS) and electronic document management systems.
Familiarity with Trial Master File (TMF) requirements and laboratory documentation best practices.
Strong organizational skills with exceptional attention to detail and the ability to manage multiple priorities.
Excellent written, verbal, and interpersonal communication skills.
Demonstrated ability to work independently while collaborating effectively within cross-functional teams.
Proficiency in Microsoft Office applications and electronic quality management systems.
Commitment to continuous learning, professional development, and promoting a culture of quality and compliance.

Nice To Haves

Cell and Gene Therapy experience is preferred.

Responsibilities

Ensure internal, central, and local clinical laboratory activities are conducted in compliance with applicable Good Laboratory Practice (GLP) regulations, GCP requirements where applicable, company procedures, and industry standards.
Monitor regulatory updates and emerging industry trends to ensure continued compliance and implementation of best practices.
Support quality oversight of laboratory activities throughout the clinical study lifecycle.
Develop, implement, maintain, and continuously improve laboratory quality control processes and procedures.
Perform routine quality reviews and assessments to identify compliance gaps and opportunities for process improvement.
Support the implementation of corrective and preventive actions (CAPAs) to address identified issues.
Assist in planning, coordinating, and conducting internal laboratory audits to evaluate compliance with GLP requirements.
Support regulatory inspections and external audits by preparing documentation, coordinating responses, and tracking commitments through completion.
Participate in inspection readiness activities and support continuous audit preparedness.
Review, maintain, and oversee controlled laboratory documentation, including Standard Operating Procedures (SOPs), protocols, reports, specifications, and quality records.
Ensure laboratory documentation is accurate, complete, current, and compliant with GLP requirements and internal Quality Management System (QMS) procedures.
Ensure laboratory-related Trial Master File (TMF) documentation is complete, accurate, and filed in a timely manner.
Support the development and delivery of GLP training for laboratory personnel.
Provide guidance on quality processes, documentation standards, and regulatory expectations.
Promote a culture of quality, compliance, and continuous learning across laboratory operations.
Assist in identifying, assessing, and documenting quality and compliance risks related to laboratory activities.
Support the development and implementation of risk mitigation strategies.
Monitor quality trends and recommend improvements to reduce compliance risk.
Participate in continuous improvement initiatives that enhance laboratory quality systems, operational efficiency, and regulatory compliance.
Collaborate with cross-functional stakeholders to implement process improvements and share best practices.
Support quality metrics, trend analysis, and effectiveness monitoring.
Partner with Clinical Operations, Translational Medicine, Regulatory Affairs, and laboratory vendors to support quality initiatives.
Communicate quality-related issues, compliance status, risks, and improvement opportunities to management and key stakeholders.
Foster collaborative relationships that support high-quality laboratory operations and inspection readiness.