Sr. Director - Global Process Owner - Supplier Quality Management at Eli Lilly and Company

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

10+ years’ experience in the pharmaceutical or other regulated industry with demonstrated knowledge and application of applicable regulations and quality systems including leadership role or role of direct influence
Bachelor’s degree in sciences, engineering, or other healthcare-related field

Responsibilities

Establish and maintain the global quality system for Supplier (Third Party) Quality Management to drive standardization globally
Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations
Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset
Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement
Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics
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 to drive further improvements
Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools
Actively collaborate with enterprise-wide teams on standardized global business processes
As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed
Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to supplier quality management
Provide strategic oversight and expertise for the global supplier quality management process, including Global Quality System standards, practices, business processes, implementation tools and associated IT systems
Lead Third Party Quality Management Community of Practice, including Global Process Leads and Area Process Owners
Lead key global projects and priorities within the Quality System
Consult with supply chain, procurement, manufacturing sites, research and development, technical services, regulatory, external parties and other functions to educate on the quality system, and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles

Skills

Supplier Quality Management

Quality Systems

Process Standardization

Third Party Quality

Global Standards

Compliance

Supply Chain

Procurement

Regulatory Affairs

IT Systems

Training

Project Leadership

Community of Practice

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.

Land your dream remote job 3x faster with AI

Try Jobo Free