Senior Scientist, Quality Assurance 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

PharmaceuticalsIndustries

Requirements

Experience in Quality Assurance
Knowledge of GMP (Good Manufacturing Practices)
Ability to lead, mentor, and coach operations and support personnel
Strong understanding of deviations, change controls, and validations
Ability to assess and triage deviations
Ability to work with Lilly support groups and external partners

Responsibilities

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
Leads, mentors, and coaches operations and support personnel on quality matters
Ensures regular presence in operational areas to monitor GMP programs and quality systems
Serves as the Quality point of contact on the local process team, as outlined in Lilly’s Manufacturing Standards for Operational Excellence
Assess and triages deviations that occur within the local process team
Works with Lilly support groups and external partners to resolve or provide advice on product related issues
Participates in self-led inspections and provides support during regulatory inspections

Skills

Key technologies and capabilities for this role

GMPQuality AssuranceDeviationsChange ControlsValidationsRegulatory InspectionsMentoringSafety Management

Questions & Answers

Common questions about this position

Is this position remote or onsite?

The position is onsite in Alzey, Germany.

What is the salary for this Senior Scientist role?

This information is not specified in the job description.

What skills and experience are required for this Quality Assurance role?

Key requirements include experience in Quality Assurance, knowledge of GMP, ability to lead and mentor personnel, strong understanding of deviations, change controls, and validations, and skills in assessing deviations.

What is the company culture like at Eli Lilly?

Eli Lilly focuses on uniting caring with discovery to improve lives, emphasizes safety with responsibility for a safe work environment and Health, Safety, and Environmental goals, and supports operational excellence through standards like Lilly’s Manufacturing Standards for Operational Excellence.

What makes a strong candidate for this Senior Scientist position?

Strong candidates will have QA experience, GMP knowledge, leadership skills to mentor teams, expertise in handling deviations and validations, and the ability to ensure GMP compliance and inspection readiness in manufacturing.

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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