Sr. Director - Computer System Validation Global Process Owner
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 17, 2025
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Job Description:
At Lilly, we unite caring with discovery to make life better for
people around the world. We are a global healthcare leader
headquartered in Indianapolis, Indiana. Our employees around the
world work to discover and bring life-changing medicines to those
who need them, improve the understanding and management of disease,
and give back to our communities through philanthropy and
volunteerism. We give our best effort to our work, and we put
people first. We’re looking for people who are determined to make
life better for people around the world. About the job At Lilly, we
unite caring with discovery to make life better for people around
the world. We are a global healthcare leader headquartered in
Indianapolis, Indiana. Our employees around the world work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back
to our communities through philanthropy and volunteerism. We give
our best effort to our work, and we put people first. We’re looking
for people who are determined to make life better for people around
the world. Responsibilities : The Senior Director, Global Process
Owner for Computer System Validation (CSV), as a leader within the
Global Information Systems Quality team, will establish and
maintain the global quality system for computer system validation,
including Global Quality standards, global procedures, required
tools and associated IT systems. Additionally, the Global Process
Owner will lead the CSV strategic evolution within GISQ. They will
manage key global projects and priorities within the Quality
System, including driving enhancements to the CSV quality system
from a current state to a desired future state. The Global Process
Owner will consult with the Tech@Lilly organization and other
Quality functions to further align on CSV standards, operations,
and other regulatory expectations to proactively ensure compliance
of Lilly’s Quality Systems. Key Objectives/Deliverables The Global
Process Owner for CSV is responsible for: Establishing and
maintaining the global quality system for Computer System
Validation to drive standardization globally. Own the global
procedures, processes, training, and implementation tools are
designed according to regulatory, industry and company expectations
(with opportunities to influence regulators) Provide governance and
oversight for improvement and CSV strategic initiatives and
fostering a robust compliance and bold mindset. Ensuring processes
are executed consistently across the organization and monitor
signals to drive continuous improvement. Act as the leader and SME
to ensure supporting IT applications and analytical tools are
configured and maintained to support the business needs and
facilitates accurate reporting and analytics. Defining a common set
of global effectiveness and efficiency metrics to drive end-to-end
performance. Monitoring performance metrics, reporting and
providing insights to inform decision making to drive further
improvements. Leading a community of cross-functional SME’s to
collaborate on proposed changes and deepen the knowledge of the
associated processes & tools. As the subject matter expert,
directly interact with Health Authorities during inspections and
draft responses to observations as needed. Ensure supporting IT
applications and tools are configured and maintained to support the
business needs and facilitates accurate reporting and analytics.
Actively engage in external organizations and industry
organizations to monitor policy changes for regulatory / external
environments and advocate / influence quality related policies and
regulatory requirements related to CSV. Basic Requirements: 12
years pharmaceutical industry experience, including leading
Computer System Validation efforts or other equivalent Quality
leadership experience Bachelor’s degree in Computer Systems or
other Life Science-related field. 5 years experience with GxP and
quality management systems, including experience related to EU and
US guidance and regulations. Proven experience leading or
supporting regulatory inspections (e.g., FDA, EMA) Additional
Skills/Preferences: Expertise in developing scalable and
standardized processes across global operations to improve
efficiency and reduce complexity. Demonstrated influential
leadership expertise and experience with senior-level IT
interactions within GxP functional areas and Global Quality. Proven
ability to work in a matrixed organization leading diverse teams
and influencing areas not under direct control. Experience leading
a major multi-site or global functions improvement initiative.
Strong strategic thinking capability with a focus on the ability to
execute strategic decisions while balancing conflicting priorities.
Proficiency in addressing operational challenges through structured
approaches and innovative solutions. Ability to drive process
improvements and strategic decisions by analyzing and interpreting
complex data. Demonstrated change agility in anticipating and
leading others through change and ambiguity. Excellent teamwork,
interpersonal, and communication skills, with the ability to
communicate and collaborate at all levels through various formats.
Expertise in developing scalable and standardized processes across
global operations to improve efficiency and reduce complexity.
Demonstrated influential leadership expertise and experience
engaging with senior-level functional leads. Strong leadership
capability to make and act on decisions while balancing speed,
quality, and risk to deliver value-added business results. Strong
capabilities in establishing governance structures and proactively
addressing quality and regulatory risks. Demonstrated people
management experience. Expertise in navigating and ensuring
adherence to global regulatory standards and frameworks. Additional
Information: Must be available to travel (domestic and
international) when required (approximately 10%) Must be fluent in
English, additional languages are also recommended Role based in
Indianapolis. Lilly is dedicated to helping individuals with
disabilities to actively engage in the workforce, ensuring equal
opportunities when vying for positions. If you require
accommodation to submit a resume for a position at Lilly, please
complete the accommodation request form (
https://careers.lilly.com/us/en/workplace-accommodation ) for
further assistance. Please note this is for individuals to request
an accommodation as part of the application process and any other
correspondence will not receive a response. Lilly is proud to be an
EEO Employer and does not discriminate on the basis of age, race,
color, religion, gender identity, sex, gender expression, sexual
orientation, genetic information, ancestry, national origin,
protected veteran status, disability, or any other legally
protected status. Our employee resource groups (ERGs) offer strong
support networks for their members and are open to all employees.
Our current groups include: Africa, Middle East, Central Asia
Network, Black Employees at Lilly, Chinese Culture Network,
Japanese International Leadership Network (JILN), Lilly India
Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ
Allies), Veterans Leadership Network (VLN), Women’s Initiative for
Leading at Lilly (WILL), enAble (for people with disabilities).
Learn more about all of our groups. Actual compensation will depend
on a candidate’s education, experience, skills, and geographic
location. The anticipated wage for this position is $151,500 -
$244,200 Full-time equivalent employees also will be eligible for a
company bonus (depending, in part, on company and individual
performance). In addition, Lilly offers a comprehensive benefit
program to eligible employees, including eligibility to participate
in a 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; and
well-being benefits (e.g., employee assistance program, fitness
benefits, and employee clubs and activities).Lilly reserves the
right to amend, modify, or terminate its compensation and benefit
programs in its sole discretion and Lilly’s compensation practices
and guidelines will apply regarding the details of any promotion or
transfer of Lilly employees. WeAreLilly
Keywords: Eli Lilly and Company, Dayton , Sr. Director - Computer System Validation Global Process Owner, Science, Research & Development , Indianapolis, Ohio
