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Job Description
Global API External Manufacturing (API EM) team seeks experienced Quality Assurance Associate Director to oversee quality oversight, manage quality projects, and oversee quality of large molecule and peptide intermediate products.
API EM is responsible for ensuring safe and high-quality drug substance production at contract manufacturers to meet patient needs and provide uninterrupted supply of commercial products and delivery of key portfolio programs across diverse disease states.
Organization Overview: * Global healthcare leader headquartered in Indianapolis, Indiana * Employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism Responsibilities: * Ensure API EM operations have robust quality oversight * Manage quality projects supporting API EM and QA employees * Oversee quality of large molecule and peptide intermediate products manufactured by contract manufacturers * Ensure compliance with Lilly quality standards and CGMPs * Resolve quality issues and oversee department performance Key Deliverables: * Make decisions regarding batch quality, resolution of quality issues, and quality performance for partners * Lead API EM QA team, providing coaching and feedback to develop QA employees * Build working relationships with API EM management and strengthen contract manufacturer alliances * Establish and improve business processes between contract manufacturers and Lilly's quality systems Requirements: * Demonstrated knowledge of CGMPs * Prior experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering, and/or Regulatory Affairs * Strong written and verbal communications skills * Strong attention to detail * Understanding of statistical tools and analysis * Excellent interpersonal and networking skills * Ability to organize and prioritize multiple tasks * Demonstrated strong problem-solving and analytical thinking skills * Ability to influence diverse groups * BS in a science-related field, engineering, or equivalent experience