Director, Clinical Quality Assurance (CQA)

August 9

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Immunovant

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Dedicated to enabling normal lives for people with autoimmune diseases

Biotechnology Research

51 - 200

Description

• Lead management of GCP quality activities in support of clinical programs and trials • Ensure compliance with corporate policies, functional procedures, and applicable regulations • Support clinical study teams to enable submission-ready quality data • Serve as a Quality liaison during competent authority GCP inspections

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 (experience in immunology trials is strongly preferred) • Strong working knowledge and interpretation of global GxP regulations in drug development from pre-clinical to post-marketing safety, particularly U.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 • Comprehensive knowledge of the interrelationship among other Quality functions and other business functional areas

Benefits

• Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package • Full range of medical, dental, vision, 401k and other benefits • Unlimited paid time off • Parental leave