Senior Director, Global Process Owner - Quality Risk Management

Eli Lilly • Indianapolis, IN

129d • $151,500 - $222,200

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 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 our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Requirements

• 10+ years' experience in the pharmaceutical industry in GxP roles, with several years of Quality experience.
• Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

Nice To Haves

• Proven ability to work in a matrixed organization with diverse teams.
• Strong strategic thinking capability with a focus on executing strategic decisions.
• Proficiency in addressing operational challenges through structured approaches.
• Ability to drive process improvements and strategic decisions by analyzing complex data.
• Demonstrated change agility in leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills.
• Expertise in developing scalable and standardized processes across global operations.
• Demonstrated influential leadership expertise.
• Strong capabilities in establishing governance structures.
• Prior experience with common QRM tools and maintenance of a risk log or risk register.
• Prior experience working in at least two of Clinical Operations/Development, Pharmacovigilance, Product Research & Development, or Commercial Manufacturing.

Responsibilities

• Establish and maintain the global quality system for Quality Risk Management (QRM).
• Provide strategic oversight and expertise for the global QRM process, including Global Quality System standards, practices, business processes, implementation tools, and associated IT systems.
• Lead the QRM Community of Practice, including Global Process Leads and Area Process Owners.
• Lead key global projects and priorities within the Quality System.
• Consult with Lilly manufacturing facilities, external supplier organizations, marketing affiliate quality operations, regulatory, research and development, and other functions to educate on the quality system.
• Ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends, and scientific principles.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools.
• Provide governance, lead the implementations of improvement initiatives, and foster a robust compliance mindset.
• Monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report, and provide insights to inform decision making.
• Develop, lead, mentor, and maintain a community of cross-functional SMEs.
• Ensure inspection readiness and interact with Health Authorities during inspections.
• Engage in external organizations and industry organizations to monitor policy changes.
• Own the global risk log and global risk register.
• Support the Quality Maturity Model initiatives.

Benefits

• Eligibility to participate in a company-sponsored 401(k); pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree