Associate Director-Test-Methods​/Systems-IDM

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 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.

• Lead the design, development, and validation of innovative test methods and strategies for IDM systems, including MES, SCADA, LIMS, and other manufacturing IT/OT platforms.
• Drive the selection, implementation, and continuous improvement of testing tools, automation frameworks, and test data management solutions.
• Collaborate with cross-functional teams, including IT, Manufacturing, Quality, and Regulatory Affairs, to define testing requirements and ensure alignment with business objectives and regulatory expectations (e.g., GxP, CFR Part 11).
• Develop and maintain comprehensive test plans, protocols, and reports for various system lifecycle phases, from development through deployment and ongoing maintenance.
• Oversee the execution of testing activities, including functional, integration, performance, and validation testing, ensuring adherence to established procedures and quality standards.
• Mentor and provide technical guidance to a team of test engineers and specialists, fostering a culture of excellence and continuous learning.
• Lead efforts to identify and mitigate risks associated with test methods and systems, implementing proactive measures to prevent quality issues.
• Stay abreast of industry best practices, emerging technologies, and regulatory changes related to software testing, manufacturing IT, and data integrity.
• Contribute to the development and refinement of IDM testing policies, standards, and procedures.
• Manage vendor relationships for testing tools and services, ensuring effective collaboration and delivery.

• Bachelor's degree in Computer Science, Information Systems, Engineering, or a related technical field. A Master's degree is a plus.
• Minimum of 8-10 years of experience in software testing, quality assurance, or validation roles within a regulated industry (e.g., Pharmaceuticals, Biotechnology, Medical Devices).
• At least 3-5 years of experience in a leadership or management role, overseeing testing teams or significant testing initiatives.
• Deep understanding and hands-on experience with manufacturing IT/OT systems such as MES (e.g., Rockwell Pharma Suite, Werum PAS-X), SCADA, DCS, LIMS, or similar systems.
• Proven expertise in developing and implementing robust test methodologies, including test automation strategies and frameworks.
• Strong knowledge of GxP regulations, 21 CFR Part 11, Data Integrity principles, and other relevant industry standards for computerized systems validation.
• Experience with various testing tools and technologies (e.g., Azure Dev Ops, HP ALM, Selenium, UFT, JIRA, SQL).
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
• Ability to manage multiple projects simultaneously and adapt to changing priorities in a fast-paced environment.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

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 () 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.

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