Global CSQA Representative (R2-R4) at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

NoVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Meet minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in
Demonstrate strength, technical knowledge, and proficiency in computer systems quality assurance (CSV), particularly within Business Units

Responsibilities

Ensure assigned functional areas, projects, and/or systems comply with corporate computer system validation (CSV) standards
Provide consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures
Provide oversight for CSV execution, including approving CSV documents per corporate standards/practices
Maintain awareness of corporate and external standards as they relate to CSV
Ensure assurance of inspection readiness within supported areas
Maintain inspectional readiness by ensuring supported systems are validated in compliance with LQS/LQPs
Track all quality actions and commitments for supported areas in Quality/CAPA plans
Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly understood
Ensure all Inspection Readiness materials (e.g., Tier 1-4) are current and appropriate
Provide periodic updates to key stakeholders and escalate issues appropriately
Deliver projects, programs, and support by providing consulting and interpretation on LQS/LQPs related to supported computer systems
Provide training to customer areas on CSV-related topics as needed
Partner with Business, Business Quality, and IT customer areas to deliver business value
Understand customer, company, and Quality priorities
Review/approve documents per CSV expectations within agreed service levels or communicate timelines clearly
Engage customers and QA management in risk management discussions
Ensure suppliers of computer systems or services meet quality expectations
Escalate computer system quality issues to appropriate persons
Strive for and promote consistency within the CSQA Organization
Streamline and continuously improve by eliminating non-value added activities to focus on quality assurance
Engage in Six Sigma projects and other process improvement activities
Identify opportunities for streamlining and simplification and assist in developing improved solutions
Understand external trends and potential ramifications for supported IT areas

Skills

Key technologies and capabilities for this role

Computer Systems ValidationCSVQuality AssuranceGXP ComplianceInspection ReadinessCorporate Standards

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment opportunity.

Where is this position located?

This information is not specified in the job description.

What are the key responsibilities of the Global CSQA Representative?

The role involves ensuring compliance with corporate CSV standards, providing consultation on standards and practices, overseeing CSV execution, maintaining inspection readiness, and delivering projects and support including training.

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 values internal talent development while encouraging discussion with supervisors before applying internally.

What qualifications are needed to be considered for this role?

Candidates must meet the minimum qualifications outlined in the job description, have or obtain work authorization in the country where the position is located, and preference is given to those demonstrating strength, technical knowledge, and proficiency in Business Units subject matter.

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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