Plant Quality Leader
Eli Lilly and Company
Full-time
On-site
Indianapolis, IN
Operations
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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.