Sr. Director - API Manufacturing Quality Assurance at Eli Lilly and Company

Houston, Texas, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor's degree (STEM degree preferred)
10+ years of pharmaceutical manufacturing quality experience
5+ years of supervision/leadership experience

Responsibilities

Serve as Site Quality Leader on the Lilly Site Lead Team
Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments
Lead the API Quality Team and manage its agenda
Support quality forums (e.g., Deviation and Change Control Boards)
Develop and monitor a site Quality Plan and metrics
Coordinate and manage regulatory inspections
Review and approve manufacturing and quality system documents
Ensure adequate QA staffing and provide coaching and development
Use HR tools for performance management, staffing, and succession planning
Contribute to QA business planning and site-wide strategic planning

Skills

cGMP

GMP

Quality Assurance

Regulatory Compliance

Change Control

Deviation Management

Quality Metrics

Regulatory Inspections

API Manufacturing

Site Leadership

Compliance Systems

Quality Plan

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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