Intel Corporation is hiring a
Director, Clinical Quality Assurance in Worldwide

Summary

The job is for a Director of Clinical Quality Assurance at Immunovant, Inc., a clinical-stage biopharmaceutical company. The role involves leading the management of GCP quality activities for one or more clinical programs and trials to ensure compliance with corporate policies, 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

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 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 records
• Author and/or review QMS controlled documents which may include standard operating procedures (SOPs) in accordance with applicable regulatory requirements
• Oversee the implementation of appropriate and timely corrective actions and preventive actions (CAPAs)
• 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, for ensuring quality, accuracy, and completeness
• Collaborate with internal and/or external stakeholders to ensure management of GCP quality issues

Benefits

• Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave
• The annual base salary for this position ranges from $200,000.00 - $225,000.00