Eli Lilly and Company · 13 hours ago
Associate Director - QA
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$116K/yr - $187K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Associate Director role focuses on supporting the development and implementation of the Quality Management System (QMS) at the Indianapolis site, ensuring compliance with regulatory requirements and collaborating with various functions to enhance manufacturing operations.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Assume end-to-end process ownership and oversight of QMS elements at the site (e.g. change management, deviation management, inspection readiness, pharmacovigilance)
Provide coaching, mentoring, training and technical expertise to the site as the Subject Matter Expert (SME) for any given QMS process
Tabulate and facilitate metrics reporting to the Site Lead Team and for monitoring and continuous improvement of the QMS processes
Provide support for internal and external audits/inspections (e.g. readiness, back/front room support, coordination of inspection responses)
Lead and/or participate in the site Inspection Readiness Team and its initiatives
Provide QA support to local regulatory and global affiliates for GMP certification registrations, renewals and submissions
Stay abreast of latest trends, applications, and compliance requirements. Share trends at site applicable forums and establish strategies/actions for deployment when applicable
Participate in management review activities of the global quality systems
Contribute to the development of area specific procedures and supporting documents (e.g. required tools, resource documents and supplemental materials)
Review and approve quality system related documents
Qualification
Required
Bachelor's Degree in a science/technology/health care related field
5+ years of CGMP pharmaceutical experience
Preferred
Previous QA/QC experience in a CGMP environment
Demonstrated ability to communicate effectively, both written and verbal, and to influence others
Demonstrated ability to prioritize and handle multiple tasks concurrently
Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
Previous experience leading and implementing projects at a site level is preferred
Experience in pharmacovigilance
Ability to present information and concepts at all levels of the organization
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
Business Standard India
2026-01-14
2026-01-14
pharmaphorum
2026-01-14
Company data provided by crunchbase