BQA - Global SAP Materials and Operations
Apply NowCompany: Eli Lilly
Location: Indianapolis, IN 46227
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.
The BQA-Global SAP Materials and Operations is responsible for interacting with both the quality/business and IT organizations to ensure that the global IT systems meet the Quality Management System requirements and are in a GMP and CSQ validated and stable state. The role is also a customer liaison in the development of system training, enhancements, reports, bug fixes and trouble-shooting user's issues that arise.
Key Objectives/Deliverables:
Education:
Experience:
Additional Skills/Preferences includes:
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
$63,000 - $162,800
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
The BQA-Global SAP Materials and Operations is responsible for interacting with both the quality/business and IT organizations to ensure that the global IT systems meet the Quality Management System requirements and are in a GMP and CSQ validated and stable state. The role is also a customer liaison in the development of system training, enhancements, reports, bug fixes and trouble-shooting user's issues that arise.
Key Objectives/Deliverables:
- Own QM Global Design. Makes final decision on global design
- Perform GMP Assessments for IT Changes, Providing Change Feasibility Review (CFR) support for SAP and/or determine GMP/non-GMP impact for all system changes
- Perform Audit Trail assessments and Business Deviation write ups
- Participate in site assessment if needed. Provide additional support if global design does not meet site needs.
- Ensure SAP is compliant with GQS.
- Own requirements, Approve Test scripts, Approve Deviations and Business Changes
- Set priority for Fixes/Changes in partnership with Tech@Lilly, determine Regression testing scope.
- Consult and Educate others on SAP Quality Processes (e.g. GQS gap assessments, self inspection compliance, management review, SOPs on SOP, Change Control, and Deviation)
- Own processes and execution of GMP Classifications and Archiving (Establishing Rule of GMP Artifacts, Setting up business rules).
- Custodian of MGL__00009, Quality Assurance Representative - QP with Unlimited Disposition Authority role.
- Directly support the SAP validation processes to drive compliance and continuous improvement.
- Subject Matter Expert for cGMP's and QM business requirements for the SAP IT solution
- Represent business area requirements within SAP (and related solutions) and to influence future direction of QM module
- Ensure that Global supply chain SOPs comply with applicable regulatory, corporate, division/departmental requirements.
- Provide support for SAP Solution, and other global IT systems.
- Lead and manage projects, understanding business impact, quantifying resources and evaluating technical options.
- Enforce standards and procedures within the team and with the external service providers.
Education:
- Bachelor's Degree (or equivalent work experience).
Experience:
- Knowledge of IT System Validation Requirements.
- Competency on quality processes executed in SAP (e.g., batch release, material receipt, material status)
- Understanding of master and transactional data used in SAP business process.
- Knowledge of foundational quality systems (e.g., deviations, change management, good documentation)
- Effective Analytical, problem solving and investigative skills.
- Ability to communicate effectively in written and verbal form.
- Demonstrated interpersonal and teamwork skills.
Additional Skills/Preferences includes:
- Broader knowledge of quality processes across the sites/ networks (e.g., batch release, material movement, materials receipt).
- Ability to lead and manage projects, understanding business impact, quantifying resources and evaluating technical options.
- Assist external service providers (e.g., Infosys) in prioritization, troubleshooting and root cause analysis of trouble tickets.
- Comprehension of business integration points between functional modules.
- Knowledgeable in all SAP processes and procedures.
- SAP knowledge from a functional and/or configuration perspective.
- Knowledge of business process, data and application architecture as it pertains to the SAP solution.
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
$63,000 - $162,800
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