Associate Director - Quality Assurance - API EM

Role Summary

Associate Director – Quality Assurance (QA) API External Manufacturing. Responsible for leading QA personnel overseeing externally manufactured small molecule APIs and Intermediates, ensuring quality systems meet cGMPs and quality agreements, and coordinating cross-functional quality activities to deliver on business and quality objectives.

Responsibilities

• Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners.
• Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
• Build working relationships with API EM management, key internal customers/partners, and strengthen CM alliances.
• Establish and improve business processes to interface between CM quality systems and Lilly quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and Quality Agreements.
• Support API EM‚Äôs efforts to maintain and improve quality systems and ensure alignment with Lilly Global Quality Standards and regulatory expectations.
• Coordinate quality activities for outsourcing of Lilly's projects to CMs, including maintaining compliant oversight practices.
• Support regulatory agency inspections at the CM, provide management status updates and participate in the resolution of regulatory findings by coordinating CM and Lilly responses.
• Ensure adequate oversight and excellence for investigations and complaints.
• Network globally to share best practices and harmonize quality practices between sites.

Qualifications

• Bachelor‚Äôs Degree in Chemistry, Biology, Biotechnology, Pharmacy, Engineering or related field.
• 8+ years of experience in a pharmaceutical manufacturing environment in TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs.

Skills

• Proven leadership, administrative, and organizational skills.
• In-depth knowledge of cGMPs and regulatory expectations.
• Ability to influence and lead diverse groups; strong communication and cross-functional collaboration.
• Strategic thinking with the ability to balance short-term needs with long-term business evolution.
• Strong analytical and problem-solving skills; project management capabilities.
• Ability to manage complex, cross-functional projects and maintain attention to detail and quality/compliance.

Education

• As listed in Qualifications: Bachelor‚Äôs Degree in scientific disciplines.

Additional Requirements

• 10 ‚Äì 20% travel may be required.
• Some off-shift work (night/weekend) may be required to support 24/7 operations.
• Onsite in Indianapolis, IN; remote work not approved.