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

Expertise in quality systems development, implementation, and management within a regulated industry (e.g., pharmaceuticals)
Knowledge of external requirements, standards, and procedures for practical application and interpretation
Experience handling deviations, change controls, Notification to Management (NTM), root cause analysis, and corrective/preventive actions (CAPA)
Skills in risk assessments, audit planning, self-inspections, and quality planning
Ability to provide quality oversight, monitor compliance, analyze metrics/trends, and drive process improvements
Proficiency in audit/inspection support, including preparation, coordination, responses, and corrective action plans
Strong collaboration and partnership skills with business areas like Data Management and external parties (e.g., third-party organizations, alliance partners)
Capability to contribute to procedures, tools, training, and documentation

Responsibilities

Contribute to the development of area-specific procedures, tools, resource documents, and supplemental materials, including review and content approval of quality system documents
Ensure regional/affiliate quality system requirements have clear accountabilities
Recommend new quality system documents or changes to existing ones
Advise on appropriate training for implementation and documentation
Provide consultation on interpretation and practical application of external requirements, standards, and procedures
Manage deviations, change controls, NTM, ensuring 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 based on identified signals/risks/gaps
Complete self-inspections and drive meaningful, actionable improvements
Ensure local implementation of quality systems and support external party management
Monitor compliance to quality system documents in Data Management, anticipate gaps, propose solutions, communicate/escalate to management
Ensure implementation of regional/affiliate Quality Plan(s), monitor progress, provide updates
Seek and implement simplification and process improvements; coordinate quality improvement initiatives
Review metrics/trending, compile compliance metrics, analyze trends, identify weaknesses/gaps, recommend corrective actions (e.g., PRAC assessment reports)
Monitor completion of deviations, change controls, CAPA, audit responses
Provide support for audits/inspections (preparation/readiness, coordination, back/front room, responses)
Ensure inspection readiness (e.g., organization of documents like training records, job descriptions)
Ensure completion of audit corrective action plans and timely resolution; lead/support readiness activities with business partners
Serve as initial point of consultation for Data Management on quality questions
Partner with Data Management to strengthen quality controls, share learnings, drive simplification, and replicate best practices
Collaborate with other quality functions

Skills

Quality Systems Management

CAPA

Root Cause Analysis

Change Control

Deviation Management

Risk Assessment

Audit Planning

Inspection Support

Compliance

GMP

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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