d) at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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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

Master Degree, or Bachelor with extensive practical experience in GMP, management science related field is preferred
Sufficient qualification for Head of Quality Control
Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
Experience with Devices and Incoming goods testing
Previous experience with Laboratory IT systems such as LIMS and LES
People management
Fluent written and oral skills in German and English
Participated in Regulatory inspections such as EMA, FDA
Additional Skills/Preferences: Management experience of third-party laboratories; Demonstrated knowledge and application of regulations as applicable to the pharmaceutical industry and related quality systems; Ability to mentor/train others, share learning
Primary location is Alzey, Germany; Ability to travel (approximately 10-20%)

Responsibilities

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals
Ensure and enforce compliance with all cGMP procedures, Quality Systems and Good Documentation Practices in Device and Incoming Testing lab
Leading the laboratory personnel, give direction and set standards
Supervise the activities within Device and Incoming Testing labs, including but not limited to: Perform laboratory device testing for commercial product; Manage incoming goods testing for commercial product; Method Transfer/Verification/Validation
Participate in flow teams and process teams to ensure smooth collaboration with other departments
Change management, Deviation management, Laboratory Investigations
Organizing the lab following 5S principle
Ensure all the Analysts/Technician within Device and Incoming Testing lab are properly trained
Build and maintaining working relationships with Device and Incoming testing labs across Lilly network
Oversee QC laboratory equipment setup and qualification, computer system validation and operation in Device and Incoming Testing lab
Support regulatory submission and inspections on behalf of Device and Incoming Testing lab

Skills

Quality Assurance

Device Testing

Incoming Goods Testing

Parental Manufacturing

Device Assembly

Packaging

HSE

Safety 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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