Director, Clinical Quality Assurance – CQA

Immunovant

Director, Clinical Quality Assurance at Immunovant overseeing GCP quality activities for clinical trials. Leading compliance efforts and ensuring quality standards across clinical program portfolio.

Posted 5/27/2026full-timeRemote • North Carolina • 🇺🇸 United StatesLead💰 $210,000 - $235,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s) and trial(s) to ensure the execution of a phase-appropriate, fit-for-purpose Audit Program
Represent Quality at cross-functional clinical program meetings and Clinical Study Team meetings and operational activities to provide appropriate Quality guidance on GCP compliance matters to internal departments.
Identify, mitigate, or escalate clinical quality risks by leveraging GCP knowledge and best practices across all phases of clinical development.
Maintain program oversight and influence proactive quality management through quality related activities with regard to vendor management, study conduct, and study
Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
Oversee the implementation of appropriate and timely Deviation, Investigations and
Participate in risk review meetings and review study Risk Management
Conduct QA reviews of essential documents including as applicable Clinical Protocols, Study Plans/Manuals, Investigator Brochures, Investigator’s Brochure, for ensuring quality, accuracy, and completeness
Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues, CAPAs, and change controls
Identify process improvements to build compliance into the design and conduct of clinical activities
Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors

Requirements

What you’ll need

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 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 (CMC Quality, Quality Systems, Audit Management, Vendor Management) and other business functional areas (Biostatistics, Clinical Development, Clinical Operations, Clinical Laboratory, CMC Operations, Data Management, Drug Safety and Pharmacovigilance, Regulatory, Supply Chain, and Program Management) to serve as a good business partner.

Benefits

Comp & perks

Equity 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

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Hard Skills & Tools

Clinical Quality Audit PlanGCP complianceQuality Management System (QMS)Deviation InvestigationsRisk ManagementQA reviewsClinical ProtocolsCAPAsInspection ReadinessGxP regulations

Soft Skills

leadershipteam motivationcross-functional collaborationprocess improvementquality guidancerisk identificationstakeholder managementcommunicationproblem-solvingcustomer focus