Sr. Principal Associate

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.

Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.

Position Brand Description: 

This position is responsible for driving Operational Excellence at the site as it relates to key quality processes.  This position will partner with Quality and Site Leadership (Quality Lead Team, Flow Team, Process Teams, etc) to drive initiatives that will result in increased capability, employee engagement, improved business results and outcomes, and ultimately, a stronger quality culture.

This position will be the site process owner for key quality processes (e.g. change, deviation), provide consultation to site resources responsible for executing these quality processes, and facilitate key governance forums in support of these quality processes (e.g. CRB, QLT, DRB).  This position is also responsible for analyzing quality data to help identify opportunities for improvement and presenting these analyses at the appropriate avenue/forum (e.g.  Quality Metrics at Quality Lead Team and other relevant process/flow teams, quality sections of Annual Product Review).

This position will partner with cross-functional groups and management with inspection readiness activities and provide assistance during regulatory agency/partner inspections including direct interaction, as required.

Key Objectives/Deliverables: 

Manage for Results /Strategic Planning: 

1) Serve as the site process owner for key quality processes, specifically Change Management Program site lead.  Provide consultation on these processes to ensure the consistent and compliant execution of these processes.

2) Lead large scale quality projects or initiatives with varying levels of complexity for the site.

3) Interface, as appropriate, with corporate groups and other sites to ensure alignment across the quality network.

4) Establish, analyze, and report quality metrics for Process, Flow and Quality Lead Teams and support the on-time performance metric. Utilize metrics and other tools to monitor the state of compliance and recommend/implement improvements accordingly.

5) Lead and manage the revisions to site quality compliance programs, as required.

6) Develop and conduct quality systems training for the site (e.g. change management, deviation management, TrackWise, etc.)

7) Facilitate key quality forums such as Quality Lead Team, Change Review Board, or Deviation Review Board (manage agenda, minutes, and follow-up actions)

8) Author/Investigate/Evaluate/Review/Approve changes, deviations, documents, as required. Author quality sections of APR, as applicable.

9) Ensure timely completion of all quality plan objectives and milestones.

10) Prepare site for regulatory and partner inspections.  Interact with regulatory agencies as required.

Basic Requirements: 

Additional Preferences: 

Other Information:  

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 ( Lilly_Recruiting_Compliance@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.

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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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