Job Information
Lilly Principal Associate-Quality in Indianapolis, Indiana
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.
Position Brand Description:
The Quality Principal Associate is part of the Global Quality Compliance (GQC) division. This position assures that the compliance processes and procedures are in accordance with company requirements, current regulations, and guidelines. This position has a particular focus on the development, approval, management, maintenance and oversight of key data in SAP, TrackWise (TW), Electronic Document Management Systems, SharePoint, Data Analytics tools, digital portals, and other computer systems. The Principal Associate is responsible for working within quality management systems across the globe to drive global data integrity, quality, and consistency. Additionally, the Principal Associate is the lead contributor to the GQC Knowledge Management program and will serve as the GQC expert. This position plays a key part in contributing to the implementation of this strategic approach to GQC oversight within Lilly.
GQC operates as a valued business partner with manufacturing and procurement, taking a proactive approach to further enhance the quality status of business operations and regulatory compliance. This position plays a key part in contributing to the implementation of this strategic approach to GQC oversight within Lilly.
Key Objectives/Deliverables: (These responsibilities are not intended to be all-inclusive)
Collaborate with manufacturing sites/affiliates across the globe to design and maintain the systems and business processes to manage data in SAP and other systems (data stewardship).
Advise and Educate GQC and the manufacturing sites/affiliates on appropriate management of data in IT systems.
Identify and Document system issues, investigate data related discrepancies and troubleshoot issues encountered by end users, while working with other GQC quality team members, IT and corporate SAP support personnel, when necessary, to resolve these issues.
Collaborate with manufacturing sites/affiliates to ensure proper IT systems training is identified and delivered to site/affiliate users.
Interface and collaborate with Global IT support and Business Integrators for GQC data.
Provide oversight, monitor business practices and ensure the quality, consistency and integrity of GQC data in all IT systems.
Understand and explain the technical aspects of SAP and Trackwise global solutions, as well as IT SOPs to Quality leadership.
Participate in testing Quality IT systems and interfaces when updates or changes are made to these systems and related Quality data fields within other business systems.
Develop and maintain local Quality SOPs for managing and maintaining global GQC data and systems.
Maintain Global Business & IT methodologies and standards for all IT systems
Develop and maintain metric reports in the IT systems and provide Global data trending and metrics to management.
Maintain the SharePoint sites for the GQC organization.
Consulting
Provide support to manufacturing site/affiliate and GQC IT system end users for routine activities and troubleshooting issues.
Maintain efficient communications to the relevant groups within the company and with appropriate outside organizations.
Participate and/or support teams, committees or other groups or work individually to achieve the department, site and company goals.
Participate or lead GQC improvement efforts, including Six Sigma projects, project management of projects and departmental teams, as assigned.
Personal Development and Shared Learning
Attend training courses, conferences, or association meetings to continue to gain knowledge in Knowledge management, change management, and IT systems/processes.
Share such information with other members of the team or company to increase awareness and to train others in the implementation of these practices.
Be continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirements.
Participate in applicable external industry groups and forums.
Minimum Requirements:
Minimum Bachelor’s degree or equivalent in a technical field, such as IT, Chemistry, Engineering, or other technical areas of study.
5 + years of experience in at least two functions of Manufacturing Operations, Quality, or IT is required.
Experience/expertise in SAP is required.
Experience in TrackWise, Veeva QualityDocs, and SharePoint sites is required.
Additional Skills/Preferences:
Flexibility to effectively prioritize work activities to meet regulated timelines.
Ability to work across functional areas with people at all levels of the organization.
Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.
Demonstrated ability to communicate and deliver constructive feedback to customers and collaboration partners, including excellent oral and written communication and oral presentation skills.
Ability to work independently and as part of a team with minimal supervision
MP Certification is preferred.
Other Information:
Must be able to travel 10% including international travel.
Position is located at LCC.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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