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

Eli Lilly and Company; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

A leading healthcare company is seeking an Engineering and Computer Systems Quality Associate Director to oversee quality operations at a new advanced research facility. The role involves managing quality oversight for facilities and digital systems, ensuring compliance with quality standards, and leading a team in a dynamic environment.

Benefits

401(k)

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Life insurance

Employee assistance program

Qualifications

• 5+ years of technical and/or quality experience in the Biopharmaceutical industry.
• Experience with large-scale capital project deliveries.

Responsibilities

• Lead a team providing Quality oversight for Facilities, Utilities, Maintenance, and Equipment.
• Manage internal and external stakeholders effectively.
• Evaluate and approve computer system/software related change controls.

Skills

Project management

Communication

Coaching

Data integrity

Education

BA/BS degree in Engineering

Job description

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 providing quality oversights for facilities, utilities, commissioning and qualification efforts, and/or maintenance programs.
• Project management and delivery of medium to large cross-functional initiatives.
• Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Ability to input and influence decision making for complex technical issues.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Experience with networking across industry, such as with industry groups or committees.
• Success in coaching, developing personnel, and mentorship.
• Ability to establish key relationships and influence peers and business partners.
• Strong communication skills.
• Ability to identify and prioritize issues, develop, and implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis

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

$118,500 - $173,800

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.

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