Plant Quality Leader

Role Summary

The Plant Quality Leader in Indianapolis Parenteral Manufacturing serves as the leader for the quality assurance organization in one of the plants. They are responsible to lead and develop the QA team, manage compliance to cGMP procedures, policies, and guidelines, support issue resolution, and approve recommendations related to product quality. They work cross-functionally to lead the plant by supporting key initiatives and ensuring safety, quality, and compliance culture.

Responsibilities

• Team and Personnel Development: participate in HR planning and performance management for direct reports, recruit new talent, and grow team capabilities; develop individuals and team for continuous professional development; sponsor and support site Safety, Quality, and Compliance initiatives and culture.
• Plant Leadership: maintain a safe work environment; influence plant agenda to ensure reliable supply of quality medicine, strong quality culture, and cGMP compliance and inspection readiness; participate on plant lead and quality teams; serve as a conduit for site, network, and corporate communications; integrate support groups outside plant; benchmark with other Lilly sites and PR&D for best practices.
• Plant Quality and Compliance Oversight: make critical quality decisions, escalate issues, create and manage Site Quality Plan, ensure inspection readiness; coordinate regulatory inspections; guide investigations and gaps; approve or reject technical and quality documents requiring quality director level approval; ensure quality oversight for manufacturing operations; act as primary back-up for other QA Directors and Site Quality Leader when delegated.

Qualifications

• Required: BSc or MSc in chemistry, biology, microbiology, pharmacy, engineering, or equivalent; 8+ years of pharmaceutical industry leadership experience.
• Preferred: strong knowledge of cGMP, Regulations, and Lilly Quality Systems; experience across Production, Quality Control, QA, Technical Services, or Regulatory; strong influencing, communication, and leadership skills; ability to prioritize and solve problems; commitment to fair and equitable work environment.

Skills

• Strong communication and interpersonal skills
• Leadership and team development
• Quality systems knowledge and regulatory familiarity
• Decision-making, problem-solving, mentorship, and coaching
• Self-management, organization, and collaboration across functions

Education

• BSc or MSc in scientific/technical fields as listed above

Additional Requirements

• Overtime may be required; travel (OUS and US) may be required
• Work in various areas within the Parenteral Plant; consider allergens and mobility requirements