Backed by 5AM Ventures.
About the role
Latigo is seeking a hands-on Manager, Quality Systems and Compliance to build, operate, and continuously improve the company’s Quality Management System (QMS) in support of its clinical-stage pipeline. Reporting to the Senior Director of Quality Assurance, this individual will manage the day-to-day operation of the core quality systems, including document control, training, deviations, CAPA, change control, and quality metrics.
What they're looking for
- Bachelor’s degree in life sciences or a related field
- Minimum of 5 years of experience in Quality Assurance or Quality Systems within the biopharmaceutical, biotechnology, or pharmaceutical industry
- Working knowledge of GxP regulations (FDA, EMA, ICH), 21 CFR Part 11, and data integrity principles, experience across GCP and/or GMP preferred
- Hands-on experience administering or supporting an electronic QMS (eQMS) and core quality processes (document control, training, deviations, CAPA, change control)
- Demonstrated experience supporting audits and/or regulatory inspections
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a lean environment
More about this role
Job: Manager, Quality Systems and Compliance
Position type: Full Time
Latigo is seeking a hands-on Manager, Quality Systems and Compliance to build, operate, and continuously improve the company’s Quality Management System (QMS) in support of its clinical-stage pipeline. Reporting to the Senior Director of Quality Assurance, this individual will manage the day-to-day operation of the core quality systems, including document control, training, deviations, CAPA, change control, and quality metrics. In addition, this individual will perform audits, participate in inspection management, and support regulatory inspection readiness across GxP operations The ideal candidate is a detail-oriented quality professional who thrives in a lean, fast-paced environment and balances hands-on system ownership with practical, phase-appropriate compliance.
Quality Systems Management
- Serve as the business process owner for the electronic Quality Management System (eQMS), including user administration, process governance, workflow optimization, system enhancements, metrics, training, and continuous improvement.
- Manage the controlled document lifecycle (SOPs, policies, work instructions, forms, and...
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