Sr. Associate Manager / Lead, GMQO at Eli Lilly and Company

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Experience in quality systems, compliance, and clinical development support
Ability to contribute to development of procedures, tools, and documents
Knowledge of deviations, change controls, NTM, root cause analysis, and CAPA
Skills in risk assessments, audit planning, and quality plans
Capability to conduct self-inspections and drive improvements
Understanding of external party management (e.g., third-party organizations, partners)
Proficiency in monitoring compliance, metrics, trending, and process improvements
Experience in audits/inspections support (preparation, coordination, responses)
Partnership and consultation skills with business areas like Clinical Development

Responsibilities

Implement and manage quality systems, including development of procedures, tools, and documents
Recommend new or changes to quality system documents
Advise on training, interpretation, and application of requirements/standards
Handle deviations, change controls, NTM; ensure documentation, escalation, and completion
Consult on root cause analysis, CAPA review/approval
Provide input into risk assessments, audit planning, and quality plans
Complete self-inspections and drive actionable improvements
Ensure local implementation of quality systems and support external party management
Provide quality oversight for Clinical Development: monitor compliance, propose solutions, escalate issues
Implement regional/affiliate Quality Plans, monitor progress, provide updates
Seek process simplification/improvement and coordinate quality initiatives
Review metrics/trends, compile reports, analyze gaps, recommend actions
Monitor deviations, change controls, CAPA, audit responses
Support audits/inspections (preparation, coordination, back/front room, responses)
Ensure inspection readiness and completion of audit CAPAs
Partner with Clinical Development as point of consultation, strengthen quality controls, share learnings

Skills

Quality Systems

CAPA

Root Cause Analysis

Change Control

Deviations Management

Audit Support

Risk Assessment

Regulatory Compliance

Training Development

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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