Director, Clinical Quality Assurance (CQA)

Immunovant is seeking a Director, Clinical Quality Assurance (CQA) who will lead the management of GCP quality activities in support of one or more clinical programs and trials to drive proactive quality management, and ensure compliance with corporate policies and functional procedures, and applicable regulations.

Requirements

• A minimum of Bachelor’s degree in STEM (Science, Technology, Engineering, and Math), and/or allied medical field (Nursing, Pharmacy, etc.)
• At least seven (7) years of pharmaceutical/biotech/medical device GCP Quality Assurance (QA), Quality Management or Clinical Compliance experience in Phase 1 – 4 clinical trials including non-interventional studies
• Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly S. FDA/EU and ICH regulations and guidelines
• Broad and direct experience with competent authority inspections such as US FDA GCP BIMO Inspections (Sponsors, CROs, and/or Clinical Investigators), Pre-Approval Inspections (PAIs), etc.
• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations

Benefits

• unlimited paid time off
• parental leave
• 401k
• medical, dental, vision