Eli Lilly and Company · 2 hours ago
Associate Director - Computer System Validation Lead
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$124K/yr - $183K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Associate Director - Computer System Validation Lead will provide technical leadership in validating and maintaining computer systems to ensure compliance with regulatory requirements and support the operational excellence of new API facilities.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Oversight of computer systems validation strategies and activities across new API facilities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate
Define the risk management approach to be followed by new API facilities
Define the inspection readiness approach for new API facilities
Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements
Support Data Integrity readiness for regulatory authority inspections and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity
Ensure we have consistent and reusable CSV strategies and artifacts across all New API facilities
Participate in business plan activities and in appropriate site governance and steering teams
Create a standard approach for GMP designation and testing requirements for site systems
Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements
Must ensure security and privacy risks are considered in the design and testing of IT systems
Qualification
Required
Bachelor's Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent
10+ years experience working in a Pharma industry (i.e. GMP) and strong understanding of quality processes in IT applying to Pharma manufacturing and distribution
Experience in CSV Strategy Development and Execution
Experience in supporting regulatory audits; both readiness and audit support
Hands on experience in execution Manufacturing and/or Lab systems CSV testing in the shop floor
Preferred
Experience in Lab systems and instrument CSV
Proven leadership experience in managing cross-functional teams
Active participation in industry forums and standards organizations
Strong experience managing multiple concurrent initiatives and projects with aggressive timelines
Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions
Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues
Strong collaboration with colleagues at all levels
Demonstrated courage & integrity
Demonstrated success in influencing without authority
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships
Highly flexible, adapting to changes in priorities, requirements and processes is required
Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership
Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems
Recognized understanding of regulations governing CSV and data integrity
Benefits
Company bonus
401(k)
Pension
Vacation benefits
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
2026-01-23
Company data provided by crunchbase