Lead/Senior Lead, GMQO at Eli Lilly and Company

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Experience in quality systems management, compliance, and implementation within a regulated industry (e.g., healthcare/pharma)
Knowledge of external requirements, standards, procedures, deviations, change controls, root cause analysis, CAPA, and risk assessments
Ability to provide consultation on training, practical application of standards, and quality oversight
Skills in audit/inspection support, including preparation, coordination, readiness, and corrective action plans
Proficiency in metrics analysis, trending, reporting (e.g., PRAC assessments), and process improvement
Strong collaboration and partnership skills with business areas (e.g., Statistics) and external parties
Capability to lead self-inspections, drive improvements, and ensure local/regional implementation

Responsibilities

Contribute to development of area-specific procedures, tools, resource documents, and supplemental materials, including review and approval
Ensure regional/affiliate quality system requirements have clear accountabilities; recommend new documents or changes
Advise on training for implementation and documentation; provide consultation on interpretation and application of external requirements/standards
Manage deviations, change controls, NTM; ensure proper documentation, escalation, and completion
Consult on root cause analysis and CAPA (including review/approval); provide input into risk assessments, audit planning, and quality plans
Complete self-inspections and drive meaningful, actionable improvements; ensure local implementation of quality systems
Provide support for external party management (e.g., third-party organizations, alliance partners)
Monitor compliance in Statistics business area, anticipate gaps, propose solutions, escalate to management
Ensure implementation of regional/affiliate Quality Plans; monitor progress, provide updates, seek process improvements
Coordinate quality improvement initiatives; review metrics/trends, compile compliance metrics, analyze weaknesses, recommend actions
Monitor completion of deviations, change controls, CAPA, audit responses
Provide support for audits/inspections (preparation, coordination, back/front room, responses); ensure readiness and completion of corrective actions
Function as initial quality consultation point for Statistics business area; partner to strengthen controls, share learnings, replicate best practices
Collaborate with other quality groups and business partners on readiness activities

Skills

Quality Systems

CAPA

Root Cause Analysis

Change Controls

Deviations

Audit Support

Inspection Readiness

Risk Assessments

NTM

GMP

Quality Oversight

Training Development

Procedure 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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