Sr. Principal Scientist - Quality Assurance at Eli Lilly and Company

Durham, North Carolina, United States

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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

Experienced in Quality Assurance, particularly in manufacturing or production environments (implied by role level and responsibilities)
Technical expertise in process knowledge, equipment support, process optimization, and continuous improvement
Knowledge of Quality Management Systems, GMP compliance, and regulatory requirements
Ability to lead, mentor, and coach QA Floor, Operations teams, and Support Personnel
Skills in investigations, root cause analysis, and countermeasure development
Capability to perform technical reviews, gap assessments, and documentation analysis
Experience with regulatory inspections, inspection readiness, and self-led inspections
Strong collaboration skills for cross-functional teams and external partners
Analytical skills for metrics analysis and identifying systemic issues

Responsibilities

Support the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems
Lead, mentor, and coach QA Floor, Operations teams and Support Personnel on quality matters
Provide back up and shutdown support for QA floor reps as needed
Lead or participate in non-routine investigations, root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations
Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.)
Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives
Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation
Liaison with Lilly support groups and external partners to develop process knowledge, resolve or provide advice on product related issues
Provide guidance in operational areas to ensure robust Quality Systems and GMP compliance (documentation review, gap assessments and deviations)
Perform reviews of event documentation for technical accuracy and compliance
Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives
Participate in self-led inspections and provide support during internal / external regulatory inspections
Analyze process team metrics for awareness and identification of potential improvement opportunities
Provide support to the QA organization

Skills

Quality Assurance

Process Optimization

Continuous Improvement

Quality Management Systems

Technical Leadership

Coaching

Mentoring

Process Knowledge

Equipment Support

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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