Clinical Quality Manager

Job Summary

To support the advancement of therapies for autoimmune diseases, the remote Senior Manager/Manager, Clinical Quality will ensure complete and compliant documentation of clinical study activities while developing and executing Quality Systems across clinical development programs.

Key responsibilities

• Serve as the primary Clinical QA point of contact for a Phase 3 global study
• Collaborate with cross-functional groups to support study start-up and execution, including oversight metric input and review
• Perform clinical site audits and support clinical site inspection readiness

Required qualifications

• Bachelor's degree in a life science or equivalent knowledge and experience
• 6-12 years of experience in the biopharmaceutical industry, particularly in GCP Quality
• Ability to independently audit various operations
• Hands-on approach with a strong sense of urgency and results-driven mindset
• Experience collaborating effectively within cross-functional teams