Job: Manager, Quality Systems and Compliance
Location: Thousand Oaks or San Francisco (on-site)
Position type: Full Time
Reports to: Senior Director, Quality Assurance
Position Description:
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.
Primary Responsibilities:
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 templates), including drafting, review routing, versioning, periodic review, and archival. Maintain document lifecycle processes that support GxP, data integrity, and evolving regulatory expectations.
- Develop and generate quality metrics and trend reports; identify compliance risks and opportunities for improvement and escalate as appropriate.
- Maintain and continuously improve core QMS elements, including document control, training management, deviation management, CAPA, and change control.
- Coordinate and support Learning Management System (eLMS) activities, including training requirements, curricula, training records, and completion tracking, while developing deeper system knowledge and functional expertise. Maintain the training program to ensure GxP personnel are qualified and training records are current, accurate, and inspection ready.
Compliance and GxP Oversight
- Ensure quality systems and records comply with applicable GxP regulations and guidance (FDA, EMA, ICH), 21 CFR Part 11, and data integrity expectations.
- Provide quality support for deviations and investigations through root cause analysis and drive corrective and preventive actions (CAPA) to timely, effective closure.
- Support change control assessment, implementation, and documentation across GxP functional areas.
- Promote a culture of quality and compliance, providing guidance to functional teams on QMS processes and expectations.
Audit and Inspection Support
- Support the internal and vendor audit program, including scheduling, coordination, tracking of findings, and follow-up on commitments and CAPAs to closure.
- Assist with regulatory inspection readiness, including back-room support, document retrieval processes, and tracking of inspection responses and commitments.
- Contribute to the qualification, management, and ongoing oversight of vendors (e.g., CROs, CMOs, and specialized service providers), in partnership with QA leadership.
Cross-Functional Collaboration
- Partner with QA leadership, functional unit heads, and external consultants to implement phase-appropriate policies, procedures, and quality standards.
- Collaborate with Clinical, CMC, Regulatory Affairs, and other GxP functions to embed quality into daily operations and support program milestones.
- Support continuous improvement initiatives and the maturation of the QMS as the organization scales.
Qualifications and Requirements:
- 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.
- Excellent written and verbal communication skills, with the ability to draft clear procedures, report on quality metrics, and provide effective quality guidance to functional teams.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Project).
