Senior Clinical QA Lead: GxP Compliance & Audits

Kardigan; South San Francisco, Princeton (CA, NJ); On-site; USD 194,000 - 253,000; Full time

Job summary

Kardigan is seeking a Clinical Quality Lead to drive a culture of quality across R&D, ensuring GxP compliance and consultation on GCP/GLP/GVP guidelines. You will collaborate with cross‑functional teams to evaluate processes, SOPs, and regulatory readiness, and oversee QA functions including CAPAs and audits.

Required are strong leadership, extensive QA/GxP experience, and the ability to travel and work on site.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 7+ years in a QMS environment with discovery and development.
• Direct experience with internal/external clinical systems and process audits.
• Experience in QA audits of Clinical Investigator sites and clinical vendors.
• Experience in SOP development and GCP knowledge.
• Strong communication and leadership skills.

Responsibilities

• Partners with Clinical Development and participates in study teams for GCP compliance.
• Maintain internal audit program, schedule, and vendor list.
• Perform internal and external audits to ensure GXP compliance.
• Communicate audit results and write audit reports.
• Support QMS activities including CAPAs, inspections, deviations, risk, and change control.
• Monitor and trend GxP non-conformances and CAPAs.
• Lead or support regulatory inspections and CAPA development.
• Maintain regulatory inspection knowledge across worldwide agencies.
• Interpret global regulations to update policies and standards.
• Build cross-functional GxP compliance awareness in R&D.
• Assist training initiatives on processes and new regulations.

Skills

GxP compliance

Quality audits

CAPA

Root cause analysis

Risk management

GCP

Leadership

Communication

MS Office

SharePoint

Education

Bachelor's degree in science

Tools

SharePoint

MS Office

Job description

Kardigan is seeking a Clinical Quality Lead to drive a culture of quality across R&D, ensuring GxP compliance and consultation on GCP/GLP/GVP guidelines. You will collaborate with cross‑functional teams to evaluate processes, SOPs, and regulatory readiness, and oversee QA functions including CAPAs and audits.

Required are strong leadership, extensive QA/GxP experience, and the ability to travel and work on site.