Associate Director - QA at Eli Lilly and Company

Sesto Fiorentino, Tuscany, Italy

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Master’s degree in a scientific discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Pharmacy, Biology)
Fluent in both English and Italian
Minimum 7 years of experience in Quality Assurance and/or Quality Control within the pharmaceutical industry
At least 2 years of leadership experience in a Quality function
Knowledge of sterile processes
On-site work required, with 4 days of remote work per month

Responsibilities

Provide Quality Oversight across all operations within the Cartridge Module, ensuring strict adherence to GMPs and Global Quality Standards (GQS) in formulation, filling, and visual inspection
Lead and manage environmental monitoring activities in Grade A (end-of-batch, end-of-campaign) and Grade B areas, ensuring compliance and data integrity
Actively participate in cross-functional teams
Inspire and align your team with the company’s mission, vision, and strategic objectives, fostering a culture of accountability and continuous improvement
Manage a diverse and skilled team, promoting technical and interpersonal development through coaching, feedback, and training
Drive productivity improvements through targeted projects within your area of responsibility
Review and approve deviations, change controls, qualification protocols, job descriptions, and training curricula for your team
Ensure manufacturing operations are aligned with European GMPs and the regulatory requirements of all target markets
Support internal self-inspection programs and represent the site during regulatory inspections
Ensure adequate resources are available to support batch release activities for semi-finished products manufactured at the Sesto site
Contribute to the production of clinical trial materials

Skills

GMP

Quality Assurance

Environmental Monitoring

Sterile Injectable Production

Data Integrity

Team Leadership

Coaching

GMP Compliance

Global Quality Standards

Formulation

Filling

Visual Inspection

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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