Eli Lilly and Company

Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry

Indianapolis, Indiana, United States

Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, ManufacturingIndustries

Requirements

Candidates should possess a Bachelor’s degree in Engineering, Computer Science, or a related field, and have at least 8 years of experience in quality systems, preferably within a pharmaceutical or biopharmaceutical manufacturing environment. Strong leadership and team management skills are essential, along with a thorough understanding of GMP regulations and quality assurance principles. Experience with commissioning, qualification, and validation (IQ/OQ/PQ) activities is also required.

Responsibilities

The Engineering and Computer Systems Quality Associate Director will lead the team providing Quality oversight for Facilities, Utilities, Maintenance, and Equipment (FUME) as well as for the Computer Systems (CS) at the Lilly Medicine Foundry. This role will partner with cross-functional teams to ensure quality requirements are met and project schedules are maintained, particularly during the commissioning, qualification, and validation phases of the facility’s startup. The Associate Director will monitor capacity and allocate Quality representatives to support the project schedule and ensure successful GMP manufacturing operations are established.

Skills

Quality Oversight
Commissioning
Qualification
Validation
GMP
Digital Strategy
Facilities
Utilities
Maintenance
Equipment

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.

Key Metrics

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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