Sr./Principal Associate - QA Computer Systems

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Organization Overview:

For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

The Associate - Computer Systems Quality Assurance is responsible for oversite of computer system validation at the Eli Lilly Lebanon API Manufacturing facility. This role includes working with Automation, QC labs, and Tech@Lilly persons to develop validation strategies for the approach to computer system validation in compliance with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems standards and practices; participating in internal and external Regulatory agency inspections; conducting evaluations of internal or supplier quality practices; maintenance of inspectional readiness; and external benchmarking of computer system validation practices.

Responsibilities:

Deliver on CSV processes

• Establish and maintain CSQ support and sustainability processes.

Deliver Projects and Programs

• Understand customer, company, and Quality priorities, and support implementation goals.

• Provide linkages to partner organizations with CSV including Automation, Site Equipment Verification, Business QA, and other CSQA persons.

Grow Capabilities and Knowledge

• Mentor others in CSQA / CSV-related roles

Maintain Inspection Readiness

• Provide consulting and interpretation on Corporate Computer Systems/Data Integrity standards and practices as implemented at the LP1 facility.

• Provide cross-functional technical leadership in the event of serious quality-related issues with computer systems.

• Monitor current state of inspection-readiness.

• Escalate issues appropriately.

Streamline and Continuously Improve

• Promote common process and best practice across functions.

• Identify systemic issues and trends across functions and drive improvement activity.

• Understand the external environment/best practices and bring external learning back to Lilly.

Basic Requirements:

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a technology-related field OR 10+ years of relevant experience

• 1+ years of experience in Automation/QC Labs/IT, Quality, or computer system validation in the pharmaceutical industry

Additional Preferences:

• Direct experience with Computer Systems Validation (GAMP5) and data integrity basic principles (ALCOA+).

• Previous experience in GMP production environments

• Demonstrated strong oral and written communication skills.

• Strong interpersonal interaction skills

• Proven ability to influence quality peers, IT SMEs, and upper management.

• Previous experience in Business Quality Assurance and Automation

Additional Information:

• This is an on-site position in Lebanon, IN

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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