Manager, GLP Compliance

Job Description Manager GLP Compliance Remote- Philadelphia PA

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 Bios headquarters and labs are located in Philadelphia PA. For more information please visit 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 this way we are not only working to improve the lives of patients but of everyone involved. #CabalettaCrew.

Were 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

Manager GLP Compliance

Reporting to the Senior Director of GCP Compliance the GLP Quality Control Specialist is responsible for supporting and maintaining compliance with Good Laboratory Practice (GLP) requirements across laboratory operations that support clinical development. This role is responsible for developing implementing and maintaining quality control processes that promote regulatory compliance data integrity and operational excellence. The Manager GLP Compliance partners closely with cross-functional teams to assess monitor and continuously improve laboratory quality systems ensuring laboratory activities are conducted in accordance with applicable regulatory requirements company policies and industry best practices.

Responsibilities

GLP Compliance

• 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.

Quality Control & Quality Systems

• 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.

Audits & Inspection Readiness

• 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.

Documentation Management

• 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.

Training & Compliance

• 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.

Risk Management

• 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.

Continuous Improvement

• 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.

Cross-Functional Collaboration & Communication

• 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.

Required Qualifications

1. Bachelors degree in Biology Chemistry Clinical Laboratory Science Life Sciences or a related scientific discipline.
2. Minimum of two (2) years of hands-on experience in biopharmaceutical operations laboratory operations technical operations quality operations or a related GxP environment.
3. 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.
4. Working knowledge of Good Laboratory Practice (GLP) Good Clinical Practice (GCP) ICH guidelines and applicable FDA regulations.
5. Understanding of Quality Management Systems (QMS) and electronic document management systems.
6. Familiarity with Trial Master File (TMF) requirements and laboratory documentation best practices.
7. Cell and Gene Therapy experience is preferred.
8. Strong organizational skills with exceptional attention to detail and the ability to manage multiple priorities.
9. Excellent written verbal and interpersonal communication skills.
10. Demonstrated ability to work independently while collaborating effectively within cross-functional teams.
11. Proficiency in Microsoft Office applications and electronic quality management systems.
12. Commitment to continuous learning professional development and promoting a culture of quality and compliance.

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 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