[Remote] Senior Global Quality Auditor at Eli Lilly and Company

Chester, Maryland, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

(Not explicitly stated in the provided text)

Responsibilities

Auditing: Scheduling, preparing, conducting and reporting Global Quality audits and assessments of research and commercial operations, both internally and externally
Leadership: Leadership of audit teams – including GXP- and ability to successfully execute a portfolio of complex audits as lead or solo auditor
Mock Inspections: Participate in mock-inspections, as appropriate
Risk Assessment: Participate or lead the risk assessment of research and commercial operations
Escalation: Drive the escalation of any compliance issues or significant risks identified during audits or when conducting risk assessment
Quality Standards: Meet the requirements outlined in quality standards, quality manuals, policies, procedures, and tools
Document Revision: Identify the need and drive the revision of GQAAC quality system documents when appropriate
Policy/Procedure Development: Participate or lead the preparation and/or review of standards, policies, procedures and guidelines
Metrics & Trending: Participate or lead the preparation of organizational metrics and trending of audit findings
Guidance: Provide advice to research and manufacturing operations on the interpretation of corporate and regulatory GXP requirements
Regulatory Relationships: Establish and maintain relationships with relevant regulatory authorities

Skills

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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