Manager, GLP Compliance
Cabaletta Bio
August 08, 2026
Remote
United States
Operations
Responsibilities
- Ensure internal, central, and local clinical laboratory activities comply with GLP (and applicable GCP), company procedures, and industry standards.
- Monitor regulatory updates and industry trends to maintain compliance.
- Provide quality oversight across the clinical study lifecycle.
- Develop, implement, maintain, and continuously improve laboratory quality control processes.
- Conduct quality reviews to identify gaps and improvement opportunities.
- Support CAPAs for identified issues.
- Assist with internal GLP audits and support regulatory inspections/external audits (documentation, responses, tracking).
- Maintain controlled laboratory documentation (SOPs, protocols, reports, specifications, quality records).
- Ensure Trial Master File (TMF) documentation is complete, accurate, and timely.
- Support development/delivery of GLP training and provide guidance on quality/compliance expectations.
- Identify and document quality/compliance risks; support risk mitigation and trend monitoring.
- Participate in continuous improvement initiatives and support quality metrics/effectiveness monitoring.
- Partner cross-functionally (Clinical Ops, Translational Medicine, Regulatory Affairs, vendors) and communicate risks/status/improvements.
Required Qualifications
- BS in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or related.
- 2+ years hands-on biopharmaceutical/lab/technical/quality operations experience in a GxP environment.
- 1+ year Document Control experience (controlled documents, electronic document management, TMF).
- Working knowledge of GLP, GCP, ICH, and FDA regulations.
- Understanding of QMS and electronic document management systems; TMF requirements/documentation best practices.
- Strong organizational skills; exceptional attention to detail; manage multiple priorities.
- Excellent written/verbal/interpersonal communication; can work independently and cross-functionally.
- Proficient in Microsoft Office and electronic quality systems.
- Commitment to continuous learning and a culture of quality/compliance.
Preferred
- Cell and Gene Therapy experience.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application
- https://www.cabalettabio.com/join-our-crew
- Ensure internal, central, and local clinical laboratory activities comply with GLP (and applicable GCP), company procedures, and industry standards.
- Monitor regulatory updates and industry trends to maintain compliance.
- Provide quality oversight across the clinical study lifecycle.
- Develop, implement, maintain, and continuously improve laboratory quality control processes.
- Conduct quality reviews to identify gaps and improvement opportunities.
- Support CAPAs for identified issues.
- Assist with internal GLP audits and support regulatory inspections/external audits (documentation, responses, tracking).
- Maintain controlled laboratory documentation (SOPs, protocols, reports, specifications, quality records).
- Ensure Trial Master File (TMF) documentation is complete, accurate, and timely.
- Support development/delivery of GLP training and provide guidance on quality/compliance expectations.
- Identify and document quality/compliance risks; support risk mitigation and trend monitoring.
- Participate in continuous improvement initiatives and support quality metrics/effectiveness monitoring.
- Partner cross-functionally (Clinical Ops, Translational Medicine, Regulatory Affairs, vendors) and communicate risks/status/improvements.
Required Qualifications
- BS in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or related.
- 2+ years hands-on biopharmaceutical/lab/technical/quality operations experience in a GxP environment.
- 1+ year Document Control experience (controlled documents, electronic document management, TMF).
- Working knowledge of GLP, GCP, ICH, and FDA regulations.
- Understanding of QMS and electronic document management systems; TMF requirements/documentation best practices.
- Strong organizational skills; exceptional attention to detail; manage multiple priorities.
- Excellent written/verbal/interpersonal communication; can work independently and cross-functionally.
- Proficient in Microsoft Office and electronic quality systems.
- Commitment to continuous learning and a culture of quality/compliance.
Preferred
- Cell and Gene Therapy experience.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application
- https://www.cabalettabio.com/join-our-crew