Associate Director - Engineering and Computer Systems Quality – Lilly Medicine Foundry

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.

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 are looking for people who are determined to make life better for people around the world.

Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of API molecules for clinical trials located in Lebanon, IN.  This facility is Lilly’s largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.  Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026. 

Position Summary:

The Engineering and Computer Systems Quality Associate Director is responsible for leading the team providing Quality oversight for Facilities, Utilities, Maintenance, and Equipment (FUME) as well as for the Computer Systems (CS) at the Foundry. The Foundry is intended to be highly digital, and this position will have responsibility for Quality support related to the digital strategy at the Foundry. The Engineering and Computer Systems Quality Associate Director will partner with cross-functional teams such as Global Facilities Delivery, Engineering, Automation, and Tech@Lilly to ensure that applicable quality requirements are satisfied, and project schedules are met.

As the Foundry is currently in design and construction, this position will provide Quality oversight for commissioning, qualification, and validation strategies. This position is responsible for monitoring capacity and allocating Quality representatives to provide sufficient support and the project schedule remains on track.

Responsibilities & Scope:

• Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent.
• Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.

• Forecasting resource needs across the integrated plan and anticipating and resolving any projected resource issues before they impact project delivery.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicating and managing internal and external stakeholders.
• Proactively managing issues, proposing, and implementing plans to resolve as needed.
• Promote a positive quality culture and oversee quality presence in the respective business areas (e.g. manufacturing, laboratories).
• Participate in FUME or CS-related global communities of practice and committees as appropriate to establish and maintain a network for benchmarking and shared learning.
• Evaluate and approve computer system/software related change controls, risk assessments, excursions, and deviation investigations.  Recommend CAPAs and ensure CAPAs implemented are effective.  Ensure that quality system related changes/deviations are evaluated consistently.
• Identify and lead process improvement projects impacting multiple business areas.

Basic Qualifications:

• BA/BS degree in the Engineering, or related field
• 5+ years of technical and/or quality experience in the Biopharmaceutical industry
• Relevant experience of working on large-scale capital project deliveries is highly desirable.

Key Attributes for the Role

Demonstration of the following:

• Understanding of data integrity, computer systems validation per CGMPs, and an understanding of System/Software Development Life Cycle concepts.
• Experience