Quality Systems & Compliance Lead (GxP)

Latigo Biotherapeutics, Inc.; Thousand Oaks (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

Latigo Biotherapeutics, Inc. is seeking a hands-on Manager, Quality Systems and Compliance to build and continuously improve the QMS supporting its clinical-stage programs.

You will manage the day-to-day operation of core quality systems, including document control, training, deviations, CAPA, and change control, while preparing for regulatory inspections. Reporting to the Senior Director, Quality Assurance, you will lead audits, support inspection readiness, and collaborate with

Qualifications

• Bachelor's degree in life sciences required.
• Minimum 5 years QA/QMS experience in biopharma/biotech/pharma.
• Knowledge of GxP regs (FDA, EMA, ICH) and 21 CFR Part 11.
• Hands-on experience with an electronic QMS (eQMS) and core quality processes.
• Experience supporting audits/regulatory inspections.
• Excellent written and verbal communication; strong organizational skills.
• Proficiency with Microsoft Office tools.

Responsibilities

• Serve as business process owner for the electronic Quality Management System (eQMS), including admin, governance, workflows, enhancements, metrics, training, and continuous improvement.
• Manage the controlled document lifecycle (SOPs, policies, forms), ensuring GxP compliance and data integrity.
• Develop and generate quality metrics and trend reports; identify compliance risks and improvements.
• Maintain core QMS elements: document control, training management, deviation management, CAPA, and change control.
• Coordinate Learning Management System (eLMS) activities, training records, and completion tracking to ensure inspection readiness.
• Support internal and vendor audits; track findings and CAPAs to closure.
• Assist with regulatory inspection readiness and document retrieval processes.
• Collaborate with QA leadership and cross-functional teams to implement phase-appropriate policies and quality standards.

Skills

GxP compliance

eQMS administration

CAPA & deviation handling

Audit & inspection support

Regulatory guidance

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Latigo Biotherapeutics, Inc. is seeking a hands-on Manager, Quality Systems and Compliance to build and continuously improve the QMS supporting its clinical-stage programs.

You will manage the day-to-day operation of core quality systems, including document control, training, deviations, CAPA, and change control, while preparing for regulatory inspections. Reporting to the Senior Director, Quality Assurance, you will lead audits, support inspection readiness, and collaborate with