Associate Director, Quality Assurance – Site Data Leader at Eli Lilly and Company

Pleasant Prairie, Wisconsin, 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

Deep understanding of GMP data flows (electronic and paper)
Expertise in data management and integrity principles in operational processes
Knowledge of Computer System Validation methodologies
Strong project management leadership skills
Ability to serve as a global data management subject matter expert
Experience providing computer system quality assurance oversight during site start-up and routine operations
Capability to influence and drive improvements in corporate quality standards, business processes, organizational design, and governance
Skills in partnering with functional area data experts to anticipate and resolve data management and integrity issues
Ability to ensure education and continuous knowledge on data integrity and data management at the site
Technical leadership capabilities as an individual contributor

Responsibilities

Primary responsibility for data management activities within the Lilly Kenosha County (LKC) site
Advocate for data management across the manufacturing site and chair the site data lead team
Ensure a robust Data Integrity Program exists and is maintained within the site
Provide strong project management leadership to advance the site’s agenda
Interface with the M&Q Data Management organization to facilitate and drive improvements in data-related corporate quality standards, business processes, organizational design, and governance
Partner with functional area data experts to anticipate and resolve key data management and integrity issues, driving solutions that impact the site and align with corporate objectives
Provide computer system quality assurance oversight during the start-up and routine operation of the Lilly Kenosha County site
Transition to a site-based data management and analytics leader role for routine production
Ensure compliance and inspection readiness of the data integrity and data management program at the site level
Ensure the site’s data integrity training program facilitates the sustainment of its data integrity continuous improvement journey
Report to the Site Quality Leader with dotted-line accountability to Global Data Management leadership

Skills

Key technologies and capabilities for this role

Data ManagementData IntegrityProject ManagementQuality AssuranceData GovernanceBusiness Process ImprovementQuality Standards

Questions & Answers

Common questions about this position

What is the salary for this Associate Director position?

This information is not specified in the job description.

Is this role remote or does it require on-site work?

This information is not specified in the job description.

What key skills and experience are required for the Site Data Leader role?

The role requires strong project management leadership, deep understanding of GMP data flows (electronic and paper), application of data management and integrity principles, and expertise in Computer System Validation methodologies.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, gives best effort to work, and emphasizes philanthropy, volunteerism, and determination to improve lives.

What makes a strong candidate for this Quality Assurance role?

Strong candidates will have experience in data management, data integrity programs, project management leadership, GMP data flows, and computer system validation, along with the ability to serve as a subject matter expert and drive site-wide improvements.

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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