Manager, GLP Compliance
Cabaletta Bio
August 30, 2026
Remote
United States
Operations
Manager, GLP Compliance (Reporting to Senior Director of GCP Compliance)
Responsibilities
- Ensure clinical laboratory activities (internal, central, local) comply with GLP regulations, applicable GCP requirements, company procedures, and industry standards.
- Monitor regulatory updates and emerging industry trends to maintain compliance.
- Support quality oversight of laboratory activities across the clinical study lifecycle.
- Develop/implement/maintain/improve laboratory quality control processes; perform quality reviews to identify gaps and improvement opportunities.
- Support CAPAs for identified issues.
- Assist with internal laboratory audits; support regulatory inspections/external audits (documentation, responses, tracking commitments).
- Oversee controlled laboratory documentation (SOPs, protocols, reports, specifications, quality records) and ensure GLP/QMS compliance.
- Ensure TMF documentation is complete, accurate, and filed timely.
- Support GLP training; provide guidance on quality processes and documentation.
- Assist in identifying and mitigating quality/compliance risks; monitor quality trends.
- Participate in continuous improvement; partner with Clinical Operations, Translational Medicine, Regulatory Affairs, and vendors.
Required Qualifications
- Bachelor’s degree in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or related field.
- 2+ years hands-on experience in biopharmaceutical/lab/technical/quality operations or related GxP environment.
- 1+ year Document Control experience in a GxP environment (controlled documents, eDMS, TMF).
- Working knowledge of GLP, GCP, ICH guidelines, FDA regulations.
- QMS and electronic document management systems knowledge; familiarity with TMF requirements.
- Strong organization/attention to detail; excellent communication; independent and cross-functional collaboration.
- Proficiency in Microsoft Office and electronic quality systems; continuous learning.
Preferred
- Cell and Gene Therapy experience.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew.
Responsibilities
- Ensure clinical laboratory activities (internal, central, local) comply with GLP regulations, applicable GCP requirements, company procedures, and industry standards.
- Monitor regulatory updates and emerging industry trends to maintain compliance.
- Support quality oversight of laboratory activities across the clinical study lifecycle.
- Develop/implement/maintain/improve laboratory quality control processes; perform quality reviews to identify gaps and improvement opportunities.
- Support CAPAs for identified issues.
- Assist with internal laboratory audits; support regulatory inspections/external audits (documentation, responses, tracking commitments).
- Oversee controlled laboratory documentation (SOPs, protocols, reports, specifications, quality records) and ensure GLP/QMS compliance.
- Ensure TMF documentation is complete, accurate, and filed timely.
- Support GLP training; provide guidance on quality processes and documentation.
- Assist in identifying and mitigating quality/compliance risks; monitor quality trends.
- Participate in continuous improvement; partner with Clinical Operations, Translational Medicine, Regulatory Affairs, and vendors.
Required Qualifications
- Bachelor’s degree in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or related field.
- 2+ years hands-on experience in biopharmaceutical/lab/technical/quality operations or related GxP environment.
- 1+ year Document Control experience in a GxP environment (controlled documents, eDMS, TMF).
- Working knowledge of GLP, GCP, ICH guidelines, FDA regulations.
- QMS and electronic document management systems knowledge; familiarity with TMF requirements.
- Strong organization/attention to detail; excellent communication; independent and cross-functional collaboration.
- Proficiency in Microsoft Office and electronic quality systems; continuous learning.
Preferred
- Cell and Gene Therapy experience.
Benefits
- Competitive benefits, PTO, and stock option plans.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew.