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:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

The Computer Systems Quality Assurance role is responsible for ensuring the Functional Area(s), Project(s) or System(s) to which they are assigned are in compliance with corporate Computer System Validation (CSV) standards.  This includes providing consulting and interpretation of Corporate Computer Systems Standards and Practices (CCS-LQS/LQPs), providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within supported areas.

Key Objectives/Deliverables:

Maintain Inspectional Readiness

• Ensure supported systems are validated in compliance with CCS-LQS/LQPs
• Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
• Participate in self inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
• Ensure all Inspection Readiness materials (e.g. Tier 1-4) are current and appropriate
• Provide periodic updates to key stakeholders
• Escalate issues appropriately

Deliver Projects, Programs, and Support

• Provide consulting and interpretation on CCS-LQS/LQPs as related to the supported computer system
• Provide training to customer areas on CSV-related topics as needed
• Partner with Business, Business Quality, and IT customer areas to deliver business value
• Understand customer, company, and Quality priorities

• Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
• Engage customers and QA management in appropriate discussions of risk management
• Ensure suppliers of computer systems or services meet quality expectations
• Escalate computer system quality issues to the appropriate persons
• Strive for and promote consistency within the CSQA Organization

Streamline and Continuously Improve

• Eliminate non-value added activities in order to focus on activities which continuously improve assurance of quality.  This may include engagement in process improvement projects.
• Identify opportunity for streamlining and simplification and assist in developing improved solutions
• Understand external trends and potential ramifications for the supported IT area(s)

Grow Capabilities and Knowledge

• Share lessons learned and best practices with others
• Act as an engaged team member

Basic Requirements:

• Bachelor (4 yr College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 5+ years experience in Automation/IT or computer system validation)
• Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborate
• Proficiency with IT systems development life cycle
• Proficiency with Computer Systems Validation and demonstrated ability to right-size validation based upon risk
• Ability to focus across multiple processes (end-to-end viewpoint)
• Prior IT system development experience or QA experience

Additional Skills/Preferences:

• Understanding of process development and/or improvement (e.g. Six Sigma)
• Experience conducting risk assessments, self-inspections, audits and/or supplier assessments
• Knowledge of multiple Lilly business areas
• Broad IT technical competency
• Ability to relate system use to potential impact to products and patients
• Knowledge of  IT Best Practices (e.g., COBIT, LSEF, ITIL, GAMP)
• Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Additional Information:

• QA Representative must complete CSQA Qualification Program

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.