Senior Associate, Quality Assurance - Change Management at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

(No specific requirements provided in the job description.)

Responsibilities

Leads, mentors, and coaches operations and support personnel on the change management program
Facilitates the Site Change Review Board, providing board leadership to drive complete evaluation of proposed changes, including risk and impact assessment
Owns the site Change Management and Activity Planning programs
Serves as the site instructor for Change Management and Activity Planning programs, ensuring process compliance through the development of comprehensive procedures, work instructions, and personnel qualification documentation
Works cross-functionally with all area/function owners to manage, evaluate, implement, and document changes to ensure quality, safety, and efficacy of products
Monitors the change management program execution, ensuring timely approval and closure of change controls
Compiles, monitors, trends, and presents Change Management data
Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals

Skills

Change Management

Quality Assurance

Risk Assessment

Impact Assessment

Mentoring

Cross-Functional Collaboration

Process Compliance

Data Trending

Change Control

Safety Management

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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