(Associate) Director, Clinical Quality Assurance
Vor 2 Tagen
**Organizational Overview**:
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
**The Role**:
As the primary GCP quality point-of-contact cross-functionally for the assigned clinical program(s), the Associate Director (or Director) Clinical Quality Assurance (CQA) will be responsible for establishing and executing a fit-for-purpose, phase-appropriate Audit Program in the Quality Management Plan with the goal of submission-ready quality data, first pass approvals by competent authorities for marketing authorizations, and commercializing batoclimab to our patients. This individual contributor will be instrumental in integrating quality and compliance strategy and establishing useful tools in tracking and trending key quality and compliance metrics to drive continuous improvement throughout the lifecycle of the clinical development process across all clinical program portfolio at Immunovant. This position will serve as the primary Quality liaison during competent authority GCP inspections at Immunovant.
**Key Responsibilities**:
- Author, maintain and implement study-specific Clinical Trial Quality Management 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 guidance on GCP compliance matters to internal departments during all phases of clinical development, identify and mitigate potential clinical quality risks and escalate to management, and leverage GCP knowledge and best practices to maintain program oversight and influence proactive quality management through quality related activities
- Author and/or review QMS controlled documents which may include standard operation procedures (SOPs) accordance with applicable regulatory requirements (e.g., ICH E6, FDA, EMA, MHRA, local regulations)
- Oversee the implementation of appropriate and timely CAPAs and review study Risk Management Plans, participating in risk review meeting
- 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
- Oversee the implementation of appropriate and timely CAPAs and review study Risk Management Plans, participating in risk review meetings
- Actively support the development and deployment of Inspection Readiness/Management program to support competent authority inspections for sponsor and clinical sites & vendors
- Participate in cross functional teams to identify GCP inspection risks and lead activities to mitigate and defend business processes
- Lead partnerships with key stakeholders to deliver solutions and training that facilitate a state of inspection readiness
- Participate in the development and execution of inspection training for SMEs and support team members
- Promote performance improvement with the Clinical Study Team and key stakeholders through a proactive and engaging compliance audit and inspection readiness system
**Requirements**:
- A minimum of Bachelor's degree in STEM (Science, Technology, Engineering, and Math), and/or allied medical field (Nursing, Pharmacy, etc.)
- At least five (5) 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 Q
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