Eli Lilly and Company · 3 hours ago
Associate Director – PR&D Engineering and Computer Systems Quality – LTC-N
Indianapolis, IN
Full-time
Hybrid
Lead/Staff, Director/Executive
$123K/yr - $198K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Engineering and Computer Systems Quality Associate Director will lead a team providing Quality oversight for Facilities, Utilities, Maintenance, and Equipment, as well as for Computer Systems, ensuring compliance with Quality Standards and Good Manufacturing Practices.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, or related field
At least 5 years' experience in the Biopharmaceutical industry
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 improvements
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-09
2026-02-09
Company data provided by crunchbase