Director, Clinical Quality Assurance (cQA)
March 5
🏡 Remote – New York
Description
• Oversee the development, implementation, and oversight of GCP related QMS SOPs and Policies in compliance with all applicable regulations • Ensure clinical trials are performed in accordance with applicable study protocols and global regulations as apply • Manage cQA consultants and contractors • Manage and oversee all aspects of cQA at clinical vendors • Create/manage/maintain quality plans for the cQA department • Perform and / or manage staff performing quality audits of investigator sites and clinical vendors
Requirements
• Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other global regulatory requirements governing clinical research • Global clinical trial oversight required • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance • 8+ years of progressive global quality / regulatory compliance background in pharma/biotech and medical device industries, with a hands-on role in clinical quality operations and quality systems development • B.S./M.S. in relevant science field • Travel required between 25% and 30% of the time
Benefits
• Medical, dental, vision, and life insurance • 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution) • New hire stock options • Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down • Leave of Absence: Paid family leave, paid short- and long-term disability • Discretionary year-end bonus
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