Director/Senior Director, Global Process Owner – Sterility Assurance QMS 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 establishing and maintaining global quality system procedural requirements for Level 2 Processes related to Aseptic Processing controls (Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, Aseptic Training)
Strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools, and associated IT systems
Ability to lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners
Capability to lead key global projects and priorities within the Sterility Assurance Level 1 Program
Experience consulting with manufacturing facilities, Global and Site Quality, and other functions to educate on Sterility Assurance program requirements
Knowledge to proactively ensure compliance of the Lilly Sterility Assurance program with country agency standards, industry trends, and scientific principles
Leadership skills to act as SME (Subject Matter Expert) for supporting IT applications

Responsibilities

Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally
Own the Global Standards, Processes, Practices, Trainings, and implementation tools, ensuring they are designed according to regulatory, industry, and company expectations
Provide governance, lead 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 align with program needs

Skills

Sterility Assurance

QMS

Quality Management System

Pharmaceutical Manufacturing

Global Process Ownership

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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