Global CSQA Representative (R2-R4)

Eli Lilly and Company • Us, IN

12d • $65,250 - $169,400

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. At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. Position Description: The Global Computer Systems Quality Assurance (CSQA) role is responsible for ensuring that their assigned functional areas, projects and/or systems comply with corporate computer system validation (CSV) standards. This includes providing consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures, 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. While the primary area of responsibility for this position will be as aligned with Global Information Systems Quality (GISQ) needs, it is intended to include a significant portfolio within the Business Units organization. As such, preference will be given to candidates who can demonstrate strength, technical knowledge and proficiency in this subject matter area.

Requirements

• Bachelor (4 yr College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 3+ 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 Lilly Computer Systems Validation and demonstrated ability to right-size validation based upon risk
• Ability to focus across multiple processes (end-to-end viewpoint)

Nice To Haves

• Understanding of process development and/or improvement (e.g. Six Sigma)
• 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., LSEF, ITIL)
• Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Responsibilities

• Maintain Inspectional Readiness
• Ensure supported systems are validated in compliance with 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 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 Six Sigma projects and other process improvement activities.
• 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
• QA Representative must complete CSQA Qualification Program

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees