Associate Director – PR&D Engineering and Computer Systems Quality – LTC-N

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.

Organization 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.

Product Research and Development (PR&D) 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). The Engineering and Computer Systems Quality team is responsible for providing Quality oversight for Facilities, Utilities, Maintenance, and Equipment (FUME) as well as for the Computer Systems (CS) specifically at our Indianapolis facilities of LTC-N, B135, and the Greenwood Innovation Center (GIC).

Position Summary:

As the Engineering and Computer Systems Quality Associate Director, you will be responsible for leading the team providing Quality oversight for FUME and CS at LTC-N, B135, and the GIC. You will manage the department’s workload, conduct performance reviews, develop business plan, and coach employees.  You will partner with cross-functional teams such as Global Facilities Delivery, Engineering, Automation, Technical Services, Operations, and Tech@Lilly to ensure that applicable quality requirements are satisfied, processes are streamlined, and project schedules are met. You will also ensure all work is carried out in a compliant manner in accordance with current Quality Standards, Quality Agreements, and current Good Manufacturing Practices (cGMPs).

Responsibilities & Scope

• Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent as applicable.
• Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness through a daily management system.
• Forecasting/anticipating resource needs and resolving any projected resource issues before they impact project timelines or product delivery with short term solutions and long-term business planning.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicating and managing internal and external stakeholders including networking closely with the Engineering and Computer Systems Quality M2 at the Lilly Medicine Foundry to ensure harmonization when possible.
• 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 and ensure accountability of successful continuous improvement projects within the team.

Basic Requirements: 

• Bachelor’s degree in Engineering, or related field.
• At least 5 years’ experience in the Biopharmaceutical industry.

Additional Skills/Preferences:

• Previous QA experience
• Demonstrated interpersonal skills
• Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, etc.)
• Proven ability to lead a team and develop employees
• Proficient in influencing complaint/deviation/change authors via both verbal and written feedback
• Proven ability to envision and oversee implementation of continuous