Quality Systems & Compliance Manager (QMS, Audits)

Latigo Bio; Thousand Oaks (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Latigo Bio seeks a hands-on Manager, Quality Systems and Compliance to build, operate, and continuously improve the company’s 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 core quality systems, including document control, training, deviations, CAPA, change control, and quality metrics.

The ideal candidate is a detail-oriented quality professional who thrives in a lean, fast-paced

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum of 5 years of experience in Quality Assurance or Quality Systems within biopharmaceutical/biotech/pharma.
• Knowledge of GxP regulations (FDA, EMA, ICH) and 21 CFR Part 11; GCP/GMP experience preferred.
• Hands-on experience administering a core quality system (eQMS) and processes (document control, training, deviations, CAPA, change control).
• Experience supporting audits and regulatory inspections.

Responsibilities

• Serve as business process owner for the electronic Quality Management System (eQMS).
• Manage document lifecycle for SOPs, policies, forms, and templates with versioning and archival.
• Develop and generate quality metrics and trend reports; identify compliance risks.
• Maintain core QMS elements: document control, training, deviations, CAPA, change control.
• Coordinate Learning Management System (eLMS) activities and training records.

Skills

GxP knowledge

Auditing

Regulatory compliance

eQMS administration

Quality metrics

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Tools

eQMS

Job description

Latigo Bio seeks a hands-on Manager, Quality Systems and Compliance to build, operate, and continuously improve the company’s 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 core quality systems, including document control, training, deviations, CAPA, change control, and quality metrics.

The ideal candidate is a detail-oriented quality professional who thrives in a lean, fast-paced