Associate Director - Analytical Quality Assurance – Lilly Medicine Foundry at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, Healthcare, BiotechnologyIndustries

Requirements

Bachelor’s degree in Chemistry, or related field
Minimum of 5 years in laboratories and analytical testing and/or quality experience in the pharmaceutical industry, preferred
Relevant industry experience in highly paced working environments
Relevant experience of working on large-scale capital project deliveries is highly desirable

Responsibilities

Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent
Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness
Translate global quality standards, cGMP, and regulatory requirements into site-level procedures
Facilitate decision making within the team under tight deadlines
Effectively communicate and manage internal and external stakeholders
Proactively manage issues, propose, and implement plans to resolve as needed
Provide quality oversight in Analytical testing, namely: molecule support, qualification of new contract labs, audit support, quality system ownership, leading compliance projects for analytical within the Foundry, and quality assessments of quality documentation (e.g., deviations, change records)
Ensure that appropriate quality systems are in place and are being utilized. Facilitate quality improvement initiatives, and the implementation of new quality standards
When necessary, evaluate potential impact of incidents on quality of materials, or the integrity of data
Coach/mentor others regarding investigations are conducted for deviations, stability failures and out of specification (OOS) results. Review and approval of the corresponding documentation
Network with Lilly quality organizations in the implementation of quality laboratory systems and share best practices
Promote a positive quality culture and oversee quality presence in the respective laboratory areas

Skills

cGMP

Quality Assurance

Quality Management System

Analytical Testing

Data Integrity

Laboratory Compliance

Quality Control

GMP

Quality Oversight

Analytical Development

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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