Note: The job is a remote job and is open to candidates in USA. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Director, Clinical Quality Assurance (CQA) will lead GCP quality activities for clinical programs and trials, ensuring compliance with corporate policies and regulations while driving proactive quality management throughout the clinical development process.
Responsibilities
- 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
Skills
- 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
- 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
- Capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
- Excellent communications skills, both written and verbal
- Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally
- Strategic thinker, open-minded and flexible to adopting new ideas
- Experience in immunology trials is strongly preferred
Benefits
- Equity and other forms of compensation may be provided as part of a total compensation package
- A full range of medical, dental, vision, 401k, and other benefits
- Unlimited paid time off
- Parental leave
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