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.
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The Lilly Medicine Foundry Quality Assurance (QA) supports the delivery of the Lilly pipeline by providing oversight of the manufacturing, packaging, and distribution of the medicines needed for clinical trials (CT). As Foundry Computer Systems Quality Assurance (CSQA) Associate, you will be responsible for the oversight of several computer systems used by Foundry to provide patients with clinical trial materials. This includes automated process equipment used in on site manufacturing facilities, process historians, and a wide variety of other systems that enable clinical trial supply.

BASIC REQUIREMENTS:

• Bachelor’s degree in Science, Engineering, Computer Science, or equivalent experience in technology-related field (IT, Automation, or computer system validation).
• Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
• Experience supporting equipment with automation.

As a Foundry CSQA Associate, you will be required to complete the corporate computer systems quality assurance qualification process. You will work as part of a small team that ensures all the locally owned computer systems used within the Foundry are compliant with current computer systems validation expectations. This will include coordinating with the Foundry QA data integrity team to ensure evolving data integrity expectations are implemented in a sustainable manner. Beyond quality oversight, this role will develop solutions for Foundry QA by enhancing coordination, supporting timely decisions, and improving communications across teams.

Additional specific responsibilities include:

• Coach and mentor others in aspects of computer systems validation support, including System Development Lifecycle knowledge, problem solving, project management, and documentation design.
• Provide consultation, interpretation, and ensure adherence to local procedures, Lilly and Global standards and regulatory expectations, as applicable.
• Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans.
• Participate in self-inspections, audits, supplier assessment activities to ensure the state of qualification/validation is clearly and accurately understood.
• Work with local business partners to foster a culture of quality.
• Review and approve applicable procedures to ensure compliance with Lilly Quality standards and regulatory requirements. Assess potential gaps between local procedure and Lilly and Global standards and facilitate remediation efforts.
• Work with local business partners to influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of new and existing GMP assets including review and approval of associated GMP deliverables.
• Evaluate potential product quality impact for any GMP-related incident (change control and non-conformance), perform initial leveling, and support the investigations to ensure proper root cause analysis and establishment of effective CAPA to prevent reoccurrence.
• Perform Quality approvals for GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations.
• Ensure Foundry is audit ready at all times and participate in internal/external inspections.
• Leverage and scale technological solutions including application and bot development.
• Develop and implement continuous improvement initiatives to simplify the implementation of automated /computer-based solutions.