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

Houston, Texas, United States

Apply Now

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

Key technologies and capabilities for this role

cGMPGMPQuality AssuranceRegulatory ComplianceChange ControlDeviation ManagementQuality MetricsRegulatory InspectionsAPI ManufacturingSite LeadershipCompliance SystemsQuality Plan

Questions & Answers

Common questions about this position

What are the basic qualifications for the Sr. Director - API Manufacturing Quality Assurance role?

A Bachelor's degree (STEM degree preferred), 10+ years of pharmaceutical manufacturing quality experience, and 5+ years of supervision/leadership experience are required.

What additional skills or experiences are preferred for this position?

Preferred experiences include Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs; proficiency in statistical analysis and computer applications; strong interpersonal, communication, and networking skills; ability to influence diverse teams and manage multiple priorities; and demonstrated problem-solving and analytical thinking.

What is the salary or compensation for this role?

This information is not specified in the job description.

Is this position remote or does it require on-site work?

This information is not specified in the job description.

What does the company culture look like at Eli Lilly, especially for this role?

Eli Lilly unites caring with discovery to make life better for people around the world, putting people first and giving best effort to work; the role offers a unique opportunity to be part of the leadership team for the startup of a greenfield manufacturing site and help build the organization, facility, and culture for successful GMP operations.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free