Plant Quality Leader

Role Summary

Plant Quality Leader in Indianapolis Parenteral Manufacturing. Leads the quality assurance organization at the plant, developing the QA team, ensuring compliance with cGMP, supporting issue resolution, approving quality-related recommendations, and promoting safety, quality, and compliance culture across the site.

Responsibilities

• Lead and develop the QA team; participate in HR development, planning, performance management, recruitment, and professional development for direct reports; sponsor and support safety, quality, and compliance initiatives and culture.
• Maintain a safe work environment; support the plant business plan; ensure reliable supply of quality medicine; uphold cGMP compliance and inspection readiness; participate in plant leadership and governance, and communicate with site, network, and corporate groups.
• Manage Site Quality Plan; ensure technical and compliance consistency across plants; oversee plant inspection readiness and regulatory inspections; guide investigations and compliance gaps; approve or reject technical and quality documents requiring quality director or Site Quality Leader approval; ensure adequate quality oversight for manufacturing operations; act as primary back-up for other Quality Assurance Directors.

Qualifications

• Required: BSc or MSc in a scientific or technical field (chemistry, biology, microbiology, pharmacy, engineering, or equivalent); 8+ years of pharmaceutical industry experience with leadership experience.

Skills

• Knowledge of cGMP, external regulations, and Lilly Quality Systems requirements.
• Strong influencing, interpersonal, teamwork, and communication skills.
• Self-management, organizational skills, prioritization, decision-making, problem solving, mentorship, and coaching abilities.
• Motivation to foster a fair and equitable work environment.

Education

• BSc or MSc in scientific or technical discipline; related degree as listed above.

Additional Requirements

• Overtime may be required; potential off-shift calls; work in various plant areas with exposure to allergens; some travel (OUS and US) may be required.