Principal Associate - Global Computer Systems QA

Eli Lilly • Indianapolis, IN

85d • $63,000 - $162,800 • Remote

About The Position

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).

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.

Nice To Haves

• 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.

Responsibilities

• Ensure the functional areas, systems, and platforms to which they are assigned are in compliance with the IT QMS.
• Provide consulting and interpretation of policies and procedures.
• Provide oversight for computer systems validation (CSV) and platform qualification.
• Maintain awareness of corporate and external standards as they relate to validation and qualification.
• 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.
• Ensure all Inspection Readiness materials are current and appropriate.
• Understand customer, company, and Quality priorities, and partner with Tech@Lilly, Business Quality, and business areas to deliver value.
• 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.
• 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.
• Strive for and promote consistency within the GISQ Organization.
• Identify opportunities for streamlining and simplification and assist in developing improved solutions.
• Share lessons learned and best practices with others.
• Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives.

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree