MSAT Global Process Owner for Sterilization Validation 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, Healthcare, BiotechnologyIndustries

Requirements

Serve as technical subject matter expert for all forms of sterilization, VPHP decontamination, and depyrogenation
Technical writing and oral communication skills to effectively communicate and transfer knowledge to all levels of the organization
Ability to drive harmonization across global sites and networks (parenteral and API)
Capability to interact regularly with peers across TS/MS, QA, Regulatory, and Engineering (site and central levels)
Sense of curiosity to drive innovation in sterilization technologies, including platform and new site startup events
Expertise to represent TS/MS on the global change control board, seek alignment, and serve as change control approver

Responsibilities

Drive harmonization throughout local Lilly sites (e.g., maintain global sterilization forums, ensure global documents are current to industry standard and agency expectations, define gaps in global alignment, and coordinate gap closure)
Assume broad responsibility across parenteral and API Networks for ownership of global control strategies as implemented and executed at sites
Provide global technical leadership for projects involving the sterilization program
Share learning and ensure strategies align with technical, quality, and regulatory guidance while supporting business expectations
Play a central role in building technical capability at sites to meet regulatory expectations and business objectives
Serve as TS/MS representative on the global change control board, seeking alignment across global stewards and sites
Be responsible and influential with respect to implementation of external trends and understanding impacts to Eli Lilly
Establish and maintain the global quality system for Sterilization Validation Programs to drive standardization globally
Own the Global Standards, Processes, Practices, Trainings, and implementation tools, ensuring they meet 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 network

Skills

Sterilization Validation

QMS

Technical Services

Manufacturing Sciences

Sterility Assurance

Parenteral Manufacturing

API Manufacturing

Global Process Ownership

Regulatory Compliance

Quality Assurance

Engineering

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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