Eli Lilly and Company · 1 day ago
Senior Director, Quality Systems Lifecycle Management (R&D)
Indianapolis, IN
Full-time
Hybrid
Director/Executive
$156K/yr - $229K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Senior Director, Quality Systems Lifecycle Management (R&D) to oversee processes within the Lifecycle Management pillar of the Quality Management System, ensuring compliance and driving excellence in R&D processes throughout the product lifecycle.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Support teams and leaders of Global Process Owners (GPOs) for all R&D-relevant processes within the Lifecycle Management pillar, including:
Drug & Device Development, Non-Clinical/Discovery Programs, Clinical Management (including trial design, site engagement, data analysis, and disclosure of research results), Global Patient Safety, and Regulatory affairs according to the QMS global process framework
Align to QMS structured governance and monitoring models to deliver excellence across R&D processes in Lifecycle Management and the QMS
Design and develop models for determining the health of the QMS process ecosystem, with a focus on Enterprise & R&D-driven metrics and outcomes
Proactively ensure compliance with global regulatory standards, scientific principles, and evolving industry trends in R&D
Drive process improvements and strategic decisions by analyzing and interpreting complex R&D data
Monitor performance metrics, report, and provide insights to inform decision-making and drive further improvements in R&D processes
Develop, lead, mentor, and maintain the GPO community to collaborate on proposed improvements and deepen the knowledge of R&D processes and tools
Actively collaborate with enterprise-wide teams on standardized global business processes related to R&D and product lifecycle
Engage in external organizations and industry groups to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements in R&D
Build and maintain an inventory of R&D stakeholders, including functional leads
Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning
Collaborate with R&D teams to ensure processes are fit-for-purpose and support innovation, scientific rigor, compliance, and increased value of Quality
Qualification
Required
10+ years' experience in the pharmaceutical industry in business or quality operational roles, with significant understanding of research and development processes and/or clinical operations
Preferred
Bachelor's degree - Preferred Degree in Business or Life Science-related field
Proven ability to lead in a matrixed organization, influencing areas beyond direct control, especially in R&D environments
Experience driving multi-site or global improvement initiatives in R&D
Strong strategic thinking with ability to execute strategic decisions while balancing conflicting priorities in research and development
Skilled in analyzing complex R&D data to inform process improvements and strategic actions
Demonstrated change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts
Excellent collaboration and communication skills across all organizational levels and formats
Expertise in developing scalable and standardized processes across global R&D operations to improve efficiency and reduce complexity
Influential leadership expertise and experience engaging with senior-level R&D functional leads
Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results in R&D
Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks in research and development
Demonstrated people management experience
Expertise in navigating and ensuring adherence to global regulatory standards and frameworks relevant to R&D
Benefits
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
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
2026-01-07
2026-01-07
Company data provided by crunchbase