GSQM Operations – Specialist
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: June 26, 2025
|
|
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. Responsibilities The
Global Supplier Quality Management (GSQM) Operations Lead
Specialist is responsible for executing tasks related to Supplier
Change Notifications (SCNs) and supplier master data in SAP and
TrackWise (TW). Additional responsibilities may include functioning
as document controller for GSQM records in Veeva QDocs. The
position ensures that the GSQM organization effectively manages
SCNs and SQM data for Lilly global manufacturing networks. The
position focuses on key process controls and management of
information critical to the functioning of the GSQM program and
database for Global Quality - Suppliers and Materials Management
function. This position assists Lilly sites utilizing supplier
quality and vendor management tools to handle data requests in
multiple sources, TrackWise (TW) records, and Veeva QDocs documents
for global suppliers and service providers. This will help to
ensure site compliance with supplier change notification, risk
assessment, and many other supplier quality management (SQM)
activities. The GSQM process focus is to provide a globally
holistic process in which GMP supplier and GMP service provider’s
Supplier Quality Management activities are globally consistent,
available, and executed by a central function to maintain patient
safety, product quality, and technical elements at the highest
standard and compliance. The overall vision of the SQM process is
to increase consistency, availability, and execution of global
supplier management files for identified global SAP MPs with the
purpose of ONE voice under TEAM LILLY practices towards the
suppliers and the internal customers such as Lilly using sites
Quality teams, TSMS, procurement, and affiliates. Key
Objectives/Deliverables: The following activities will be performed
according to established procedures, guidelines, forms and tools.
These responsibilities are not intended to be all-inclusive: Serve
as SAP Local & Global Data Steward Receive GMP Supplier & Service
provider spreadsheets from Affiliate sites for processing Request
any new MP’s for Affiliate Create plant material/service level
records in SAP for the Affiliate Create the SAP, MP vendor masters
for all MP requests Review and consult with Dun & Bradstreet for
valid Duns numbers required in MP vendor master creation Potential
for SAP test case execution and SOP review Maintain SAP data for
Affiliates Perform SAP data change requests for suppliers and
service providers. General GSQM duties Manage the Supplier Change
Notification Triage process (current and new) Supplier
Communications (via email and TrackWise Digital Portal) Manage TW
supplier change records Manage SCN database records Collaborate
with auditors and management to resolve questions Maintain good
interpersonal and communication skills with auditors with
particular emphasis on verbal and written communication skills
Initiate and submit trouble tickets for system errors Provide
metrics, upon request Provide support to SQM processes that will be
managed in TW Risk Assessment Supplier Periodic Performance
Evaluations Complaints and Remarks to Suppliers GSQM Document
Control Serve as Veeva QDocs Document Controller for select GSQM
Documents Assure adherence to corporate record retention Personal
Development Be continually aware of current industry trends and
regulatory agency interpretation of GMP/cGMP and other relevant
requirements, in particular, those related to the Supplier
Management Programs. Manage training needs and maintenance of
course curriculum related to GSQM. Maintain good interpersonal and
communication skills with business areas with emphasis on verbal
and technical writing skills. Complete required training and
qualifications for the roles identified in the Individual Training
Plan (ITP) / Learning Plan (LP). Basic Qualifications Education:
High School or equivalent Minimum Requirements: Demonstrated
experience working in SAP for Supplier Management Demonstrated
experience working in Veeva QDocs Demonstrated experience with
TrackWise (Lilly CAPA System, Change Management, and Enterprise
SQM/Audit Module) Capability to advance working knowledge of Global
Supplier Quality Management processes Ability to help identify,
develop, and implement continuous improvement solutions to global
SQM processes. Proficient in MS Word, Excel, PowerPoint, SharePoint
Additional Skills/ Preferences Additional Skills/Preferences
includes: Associate's degree or other advanced education or
training Strong learning agility Strong organizational skills Good
analytical/problem-solving skills; proven ability to think and
analyze from a process perspective Work under pressure on multiple
tasks concurrently and meet deadlines in a fast-paced work
environment with frequent interruptions and changing priorities
Ability to work independently as well as collaboratively within a
global team environment Deliver constructive feedback while
providing a high level of customer service Ability to influence and
manage change/conflict Establish and maintain effective working
relationships at all levels internal and external to the company
Excellent communication (verbal and written) Positive and
professional approach Detail-oriented Additional Information
Additional Information includes: Travel is not required for this
position This job description is intended to provide a general
overview of the job requirements at the time it was prepared. The
job requirements of any position may change over time and may
include additional responsibilities not specifically described in
the job description. For GMP purposes, the job description should
be updated for significant changes. As always, you should consult
with your supervisor regarding your actual job responsibilities and
any related duties that may be required for the position. 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 $16.58 - $39.06
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, Terre Haute , GSQM Operations – Specialist, Administration, Clerical , Indianapolis, Indiana