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.

Company Overview:

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 39,000 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. #WeAreLilly

Responsibilities:

• Lead validation activities for the applications.
• Provide oversight and guidance on all aspects of the validation of the solution ensuring compliance with all government regulations and corporate policies and procedures.
• Ensure compliance with internal and external privacy policies and requirements.
• Leverage your knowledge and experience to shape the validation approach and strategy of the solution.
• Provide guidance and oversight of computer systems quality and compliance activities, including the review and approval of computer systems validation deliverables as appropriate.
• Build working understanding of configuration and integrations of the solution being implemented to ensure validation activities cover all requirements.
• Influence design and testing decisions to ensure security and privacy risks are considered and mitigated.
• Design effective, streamlined validation processes to accelerate solution delivery leveraging automated configuration verification and testing where possible.
• Lead testing effort on system releases and changes ensuring system remains in a validation state.

Basic Qualifications

• Bachelor’s degree in IT, Engineering, Computer Science or similar STEM qualification.
• Minimum of 5+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications.

Additional Skills/ Preferences:

• Experience and knowledge with FDA regulations as they pertain to information and digital solutions, especially 21 CFR Part 11, as well as relevant aspects of corporate privacy requirements.
• Experience with risk-based approach to system validation and testing.
• Experience in the development and execution of computer validation documentation and standard operating procedures.
• Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously.
• Ability to work independently, and on multiple concurrent project initiatives.
• Enthusiasm to learn and share ideas and solutions effectively with management and colleagues.

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.

#WeAreLilly