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

Chester, Maryland, 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

Expert knowledge of GXP regulations, guidelines, and industry standards
Comprehensive knowledge of applicable regulations, technical knowledge, and training to meet responsibilities
Ability to schedule, prepare, conduct, and report complex global quality audits and assessments (internal/external, including for cause, process/system, affiliates, large TPOs, pre-inspection)
Leadership of audit teams with limited supervision, including execution of a portfolio of complex audits as lead or solo auditor
Participation in mock-inspections
Participation or leadership in risk assessments of research and commercial operations
Ability to drive escalation of compliance issues or significant risks
Meet requirements of quality standards, manuals, policies, procedures, and tools

Responsibilities

Scheduling, preparing, conducting, and reporting global quality audits and assessments of research and commercial operations (internal/external) to assess compliance with company standards, policies, procedures, regulations, and guidelines
Leading audit teams and executing complex audits (e.g., for cause, process/system, affiliates, large TPOs, pre-inspection)
Participating in mock-inspections
Participating or leading risk assessments of research and commercial operations, integrating audit/risk information, and influencing actions across GQAAC and business areas
Driving escalation of compliance issues or significant risks identified during audits or risk assessments
Identifying needs and driving revisions to GQAAC quality system documents (standards, policies, procedures, guidelines)
Participating or leading preparation/review of standards, policies, procedures, and guidelines for quality requirements
Participating or leading preparation of organizational metrics and trending of audit findings
Providing advice to research and manufacturing operations on interpretation of corporate and regulatory GXP requirements
Establishing and maintaining relationships with relevant regulatory authorities, including supporting activities

Skills

Key technologies and capabilities for this role

GXPQuality AuditingGMPComplianceInternal AuditsExternal AuditsRegulatory CompliancePharmaceutical QualityPharmacovigilanceAudit Program Management

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills are required for the Senior Global Quality Auditor role?

The role requires expertise in scheduling, preparing, conducting, and reporting global quality audits, leadership of audit teams including GXP, executing complex audits as lead or solo auditor, and participating in risk assessments and mock-inspections.

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, and emphasizes giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Senior Global Quality Auditor position?

A strong candidate is an expert quality professional capable of acting as a key contributor to the GQAAC audit program, performing audits with limited supervision, leading audit teams, and driving escalation of compliance issues in GXP areas.

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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