Eli Lilly and Company · 1 day ago
PRD - Early Phase QA - Advisor/Sr. Advisor
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$126K/yr - $205K/yr
5+ years expEli Lilly and Company is a global healthcare leader dedicated to improving lives through innovative medicines. The Early Phase QA - Advisor/Sr. Advisor role involves providing technical leadership and quality oversight for early phase development assets, ensuring compliance with regulatory requirements and good manufacturing practices.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Support delivery of early phase Pre-Commercialization Information and Materials within the Early Phase portfolio (typically through Phase II); ensuring quality expectations/requirements are consistently met
Ensure appropriate execution of the Early Phase Quality System to sustain compliance with regulatory requirements and good manufacturing practices
Review and approve manufacturing documentation
Disposition API, in-process materials, dosage forms and finished drug product to be used in Clinical Trials including management and review of GMP documentation, analytical results and regulatory commitments
Coordinate deviation and complaint investigations, as needed
Review and approve deviations, change documents, and specifications for Early Phase materials
Provide QA input to CM&C Development Plans as part of Early Phase deliverables
Ensure contract manufacturers and packagers, testing laboratories, vendors, and suppliers are qualified to assure compliance and integrity of the supply chain and oversee partner activities within a manner that optimizes compliance as well as efficiency
Collaborate with internal business and quality partners (SMDD, BR&D, PD, ELECTS) to ensure appropriate Lilly oversight of Early Phase activities at external partners
Maintain and execute a Quality System aligned with LQS, GQS, and PR&D QS commensurate with Early Phase scope and phase of development
Provide on-site support at partners/CMO’s for manufacturing, packaging and labeling activities of investigational medicinal products, and materials used to produce IMPs as necessary
Provide on-site support for internal manufacturing, packaging, labeling and distribution activities of investigational medicinal products, and materials used to produce IMPs as necessary
Identify opportunities for, and participate in, continuous improvement
Ensure inspection readiness through site self-assessments, GMP education, monitoring, establishing and enhancing Quality systems and provide support for internal and regulatory site inspections
Influence PR&D QA management via identification and/or implementation of process improvement opportunities for external party governance within PR&D Early Phase
Actively monitor changes to global compliance environment, and industry developments, assess impact/compliance of Early Phase Quality system and quality strategy, and implement necessary changes
Mentor, coach and develop Early Phase QA Team Members
Qualification
Required
Demonstrated relevant experience in global clinical trial cGMP regulations
Breadth of technical and quality knowledge including API, drug product manufacturing, clinical trial packaging, analytical laboratories
Demonstrated expertise of cGMP and Quality Systems with a minimum of 5 years internal Lilly and external experience in any of QA, QC, Manufacturing MS&T, or Regulatory
Ability to interpret/apply phase-appropriate GMP standards
Proficiency with applicable computer systems
Demonstrated strong oral and written communication skills
Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills
Demonstrated attention to detail
Bachelor's degree in Science-related field or Engineering, or equivalent years of experience
Preferred
Proven ability to work independently or as part of a team to resolve an issue
Previous experience in QA, QC, Operations, TS/MS, Engineering, or Regulatory is desirable
Knowledge of PR&D Quality Systems and/or CT Operations is preferred
Experience in cGMP Auditing
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
2026-01-08
2026-01-08
2026-01-08
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