Principal Associate - Global Computer Systems QA

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: 

Global Information Systems Quality (GISQ) serves as the Quality Assurance unit for global computer systems and provides governance, application, and oversight of the IT Quality Management System (QMS) as defined in Lilly Quality Standard LQS-302 and the associated Lilly Quality Practices (LQPs).

Responsibilities:

The Global Computer Systems Quality Assurance (CSQA) is responsible for ensuring the functional areas, systems, and platforms to which they are assigned are in compliance with the IT QMS. This includes providing consulting and interpretation of policies and procedures, providing oversight for computer systems validation (CSV) and platform qualification (including reviewing and approving validation and qualification artifacts per procedure), maintaining awareness of corporate and external standards as they relate to validation and qualification, and assurance of inspection readiness within supported areas.

This posting is for a CSQA primarily supporting infrastructure platforms in Digital Core.

Key Objectives/Deliverables:

• Establish and Maintain Inspection Readiness

  • Ensure supported systems and platforms are validated or qualified in compliance with LQS/LQPs.

  • Ensure all quality actions and commitments for supported areas are appropriately tracked in CAPA plans.

  • Participate in and/or lead self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation and platform qualification is clearly and accurately understood.

  • Ensure all Inspection Readiness materials are current and appropriate.

• Influence Quality Delivery of Projects and Programs

  • Understand customer, company, and Quality priorities, and partner with Tech@Lilly, Business Quality, and business areas to deliver value.

  • Provide consulting and interpretation on LQS/LQPs as related to the supported computer systems/platforms.

  • Provide training to customers on IT quality-related topics as needed.

  • Review/approve documents per procedure within agreed service levels.

  • Engage customers and QA management in appropriate discussions of risk management.

  • Ensure suppliers of computer systems, infrastructure platforms, or services meet quality expectations.

  • Escalate computer system quality issues to the appropriate persons.

• Streamline and Continuously Improve

  • Eliminate non-value-added activities to focus on activities which continuously improve assurance of quality.

  • Proactively identify and communicate potential impacts to project timelines based on artifact approval requirements at various phases of the systems development lifecycle (SDLC).

  • Strive for and promote consistency within the GISQ Organization.

  • Identify opportunities 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.

  • Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives, etc.

Basic Requirements: 

• Bachelor’s degree in a technology-related field such as Computer Science; or equivalent experience (e.g., 4+ years’ experience in IT, Automation, or computer systems validation.

• Proficiency in cloud-based technologies

• Proficiency with IT systems development lifecycle

• Prior IT system development experience or QA experience

Additional Skills/Preferences:

• Previous experience with Computer Systems Validation/platform qualification

• Experience conducting risk assessments, self-inspections, audits and/or supplier assessments

• Familiarity with Lilly’s system infrastructure environment

• Knowledge of IT best practice frameworks and/or regulations (e.g., COBIT, LSEF, ITIL, NIST, GAMP; 21 CFR Part 11, GxP, EMA)

• IT assurance-related certifications (e.g., CISA, CSQE, ISO, ITIL)

• Understanding of process development and/or improvement (e.g. Six Sigma)

• Demonstrated influence and mentoring skills with peers and management

• Demonstrated ability to communicate with customers, including good oral and written communication skills and presentation skills

Additional Information:

• Travel: 0-5%

• CSQA Representative must complete Lilly’s CSQA Qualification Program, including an additional AI Qualification.

• This role is located at our corporate center in Indianapolis, IN and is required to be onsite with the flexibility to work from home 4 days per month.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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