Corporate Quality Manager

Overview

Employer Industry: Direct-to-Patient Healthcare

• Salary up to $153,000
• Competitive equity and benefits package
• Opportunity for career advancement within a rapidly growing healthcare company
• Flexibility to work remotely anywhere in the United States
• Collaborative work environment with in-person team interactions in the tri-state area
• Recognition as a Fortune Best Workplace in New York and Health Care for four consecutive years

• Manage the ongoing development, implementation, and maintenance of a robust Quality Program / Quality Management System across all parts of the employer
• Lead tracking, trending, and analysis of quality system metrics such as deviations, nonconformances, and CAPAs
• Prepare and present quality system data and trends to cross-functional partners
• Serve as system owner for document control, including drafting and coordinating approval of SOPs and managing document lifecycle activities
• Support inspection readiness by ensuring quality system documentation is current and accurate

• Bachelor s degree in an appropriate Science discipline
• 6+ years of experience in a Quality Assurance / Quality Systems role within a regulated environment
• Demonstrated experience supporting or leading the implementation and maintenance of a Quality Management System
• Internal and/or external audit experience
• Strong attention to detail and ability to think strategically

• Past use of data visualization tools and experience tracking and trending metrics
• Experience in SOP development, personnel training, and documenting quality events
• Working knowledge of cGMP requirements, such as 21 CFR 820 or 21 CFR 210/211
• Experience in drug compounding, specifically USP 795 or USP 797

#Direct To Patient Healthcare  #Quality Management #Career Opportunity #Remote Work #Regulatory Compliance

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