Senior Director, Global Process Owner - Quality Risk Management at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Expertise in Quality Risk Management (QRM) as a subject matter expert (SME)
Leadership experience within Global Quality Systems teams
Knowledge of regulatory standards, industry trends, and scientific principles across various country agencies
Ability to consult with manufacturing facilities, external suppliers, marketing affiliates, regulatory, R&D, and other functions
Senior leadership skills to lead communities of practice, Global Process Leads, and Area Process Owners
Experience in IT systems configuration, analytical tools, and reporting for quality processes
Capability to develop and monitor global effectiveness and efficiency metrics
Skills in inspection readiness, direct interaction with Health Authorities, and drafting responses to observations
Engagement with external and industry organizations to monitor and influence policies

Responsibilities

Establish and maintain the global quality system for Quality Risk Management (QRM) to drive standardization
Own Global Standards, Processes, Practices, Trainings, implementation tools, and associated IT systems, ensuring alignment with regulatory, industry, and company expectations
Provide strategic oversight and expertise for the global QRM process
Lead the QRM Community of Practice, including Global Process Leads and Area Process Owners
Lead key global projects and priorities within the Quality System
Provide governance, lead implementations of improvement initiatives, and foster a robust compliance mindset
Ensure processes are executed consistently across the organization and monitor signals for continuous improvement
Act as leader and SME to ensure supporting IT applications and analytical tools are configured and maintained for business needs, accurate reporting, and analytics
Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance
Monitor performance metrics, report insights, and inform decision-making for improvements
Develop, lead, mentor, and maintain a community of cross-functional SMEs for collaboration on improvements and process knowledge
Actively collaborate with enterprise-wide teams on standardized global business processes
Ensure inspection readiness, interact directly with Health Authorities during inspections, and draft responses to observations
Actively engage in external and industry organizations to monitor policy changes and advocate/influence quality-related policies and regulatory requirements for QRM
Own the global risk log and global risk register, ensuring key quality risks across the enterprise are managed

Skills

Quality Risk Management

QRM

Global Quality Systems

Strategic Oversight

Process Ownership

Quality Standards

Business Processes

Implementation Tools

IT Systems

Community of Practice

Global Projects

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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