d) at Eli Lilly and Company

Alzey, Rhineland-Palatinate, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, ManufacturingIndustries

Requirements

Ability to function as a CSQA working with Global Facility Delivery, Lilly project staff, Global CSQA, and selected External Contracting firms
Knowledge of Quality by Design (QbD) and Quality Risk Management (QRM) principles
Ability to interact with global, project, and functional areas to coordinate design and startup activities
Capability to provide technical and quality review and approval of project computer system documents
Skills to manage CSQA priorities and schedules for timely delivery
Ability to assist in Data Integrity (DI) related projects
Participation skills in Audit Trail Review and DI Assessment of Computer Systems, Interfaces, and Processes
Ability to support site organization in building technical capability and mentoring staff
Strong quality culture fostering skills, including open communications, teamwork, and employee participation
Partnership-building ability with Technology Team, system owners, and business owners
Capability to resolve or escalate compliance issues
Support skills for QA Compliance team and site readiness plan
Participation ability in self-led inspections and support during internal/external regulatory inspections
Ability to effectively review and/or redline documents to ensure quality attributes are met

Responsibilities

Complete detailed design of assigned areas employing QbD and QRM principles, ensuring integration of Global Quality System requirements
Coordinate design and startup activities to support project and site schedule; consult with Network and Global quality groups for consistent compliance
Assure computer systems (IT systems, Lab Automation, M&Q Automation) are developed, deployed, and maintained according to Lilly standards, Quality Procedures, and regulatory expectations
Provide quality oversight throughout the lifecycle of computer systems to ensure validation state
Review and approve IT/Automation systems related documents according to Risk Evaluation and Responsibilities for Computerized Systems
Manage CSQA priorities and schedules to assure timely delivery of CSQA and Lilly-Alzey objectives
Assist Data Integrity (DI) related projects for the Alzey site
Participate in Audit Trail Review of Computer Systems adhering to Global Lilly Standards
Participate in DI Assessment of Computer Systems, Interfaces, Processes to identify data vulnerabilities
Support site organization in building technical capability for cross-functional staff, including mentoring
Foster strong quality culture with open communications, teamwork, and employee participation
Establish partnership with Technology Team, system owners, business owners, providing rationale with data/Lilly guidance/priorities
Resolve or escalate compliance issues to project, site, and Quality Management
Support QA Compliance team and site in execution of site readiness plan, focusing on startup and ongoing quality oversight of Computer Systems
Participate in self-led inspections and provide support during internal/external regulatory inspections

Skills

Key technologies and capabilities for this role

Quality by DesignQuality Risk ManagementComputer System Quality AssuranceData IntegrityGlobal Quality SystemProject ManagementTechnical Review

Questions & Answers

Common questions about this position

What is the location for this position?

The role is based at the Lilly production facility in Alzey, Rhineland-Palatinate, Germany.

What are the company's core values?

Eli Lilly's three core values are Excellence, Integrity, and Respect for People.

What key responsibilities does this role involve?

The role includes functioning as a CSQA to complete detailed design using Quality by Design and Quality Risk Management, providing quality oversight for computer systems lifecycle, reviewing and approving IT/Automation documents, managing priorities, assisting Data Integrity projects, and participating in audit trail reviews and DI assessments.

Is the salary or compensation mentioned for this position?

This information is not specified in the job description.

What makes a strong candidate for this CSQA role?

Strong candidates will have expertise in computer system quality assurance, Quality by Design (QbD), Quality Risk Management (QRM), data integrity assessments, and ensuring compliance with global quality standards and regulatory expectations.

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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