Sr. Principal Associate Quality Excellence and Inspection Readiness – Lilly Medicine Foundry at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Technical leadership in quality improvement and inspection readiness
Expertise as primary subject matter expert in Quality Excellence (e.g., Quality Continuous Improvement, Audits/Inspections)
Ability to act as Quality Lead for Site Operational Excellence initiatives, with focus on Inspection Readiness workstream
Collaboration skills with site quality leadership, PR&D Quality staff, and global quality teams
Knowledge of Lean tools and systems (e.g., daily management, A3 thinking, standard work) for coaching and training Quality teams
Experience leading cross-functional teams in Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR)
Ability to prioritize projects/initiatives focused on inspection readiness and site focus areas
Skills in establishing governance, oversight, charters, and assigned teams for projects

Responsibilities

Support cross-functional teams, facilitate decision making, drive progress, establish key performance indicators, and monitor effectiveness
Act as primary subject matter expert for Quality Excellence, inclusive of Quality Continuous Improvement, Audits/Inspections
Serve as Quality Lead for Site Operational Excellence initiatives (initial focus on owning Inspection Readiness workstream for site operational readiness)
Collaborate with site quality leadership team, PR&D Quality staff, and global quality central teams to develop and manage quality continuous improvement agenda
Establish linkages with network and global teams and participate in relevant forums
Coach and train Quality teams in Lean tools and systems (e.g., daily management, A3 thinking, standard work)
Lead cross-functional teams in development and implementation of strategies for Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc
Prioritize projects and initiatives with focus on inspection readiness and alignment with site main focus areas
Establish governance to provide oversight to progress of sanctioned projects
Ensure projects/initiatives have approved charter and assigned teams

Skills

Quality Excellence

Inspection Readiness

GMP Compliance

Quality Improvement

Regulatory Compliance

Audit Management

Risk Assessment

CAPA

FDA Regulations

Technical Leadership

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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