Representative-QA MMQA at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor’s degree or equivalent experience in a science-related field
Minimum 2 years of relevant experience in a regulated environment
Experience with Lilly deviation and change control processes (preferred)
Experience in material management, quality systems and cGMPs (preferred)
Proficiency with current computer systems and applications including Microsoft Office products, SAP, EDMS and TrackWise or similar systems (preferred)
Strong oral and written communication and interpersonal skills (preferred)
Ability to influence externally with suppliers and resources across sites (preferred)

Responsibilities

Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers
Conduct material and supplier risk assessments and periodic reviews of supplier performance
Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements
Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities
Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints)
Provide input and guidance to site activities (e.g. six sigma, new product / process development, change controls) as material quality SME
Be able to perform materials SAP data steward functions, if necessary
Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary
Provide the voice of quality to the IDAP Supplier Committee, providing input and support as needed in order to ensure compliance
Support regulatory inspection activities as needed by providing documentation and SME support
Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
Work with global resources, as necessary, to achieve compliance with requirements
Lead, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Skills

Quality Oversight

Supplier Management

Risk Assessment

Quality Agreements

GMP

SAP

Six Sigma

Change Control

Materials Management

Complaint Management

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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