Sr Principal Associate

2 weeks ago

Plainfield, United States Eli Lilly Full time

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 Senior Principal Associate - QA Logistics Operations will be responsible for quality support for North America Logistics Operations (NALO) and for Export operations to the OUS affiliates. The QA Senior Principal Associate will be the primary contact for quality risk assessment.

The QA Senior Principal Associate will drive large-scale quality improvement projects and influence direction for NALO. Proven project management skills are required. The position is responsible for ensuring compliance with all GMPs, internal standards and systems, procedures, and guidelines for distribution activities.

Specific responsibilities include:

  • Practical application of ICHQ9 (Quality Risk Management) and ICHQ10 (Quality Systems) to NALO operations, using Lilly quality standards
  • Perform supplier and service provider quality management
  • Participate in and/or lead any project with quality risk management aspects
  • Collaborate with NALO site Data Leader to ensure risk assessments enables data integrity
  • Maintain a state of inspection readiness for all distribution centers under NALO control
  • Provide updates to management regarding the Quality performance within areas of support.
  • Collaborate both internally (Lilly Manufacturing) and with external business partners to identify opportunities to standardize operations, increase global harmonization, and identify improvement opportunities.
  • Network, both internally and externally, to understand best practices, share knowledge and to ensure all Quality requirements are met or exceeded.
Support the business organization by

o Timely and accurate reporting, change controls, action item completion, and investigations

o Collaborate with other functions, including hands-on work experience and shared learning

Benchmarking with other Lilly sites to gain support for solutions

Basic Qualifications:

Education: minimum educational requirement to perform the position
  • Bachelor's degree in Engineering, Pharmacy or related science degree, or equivalent experience
  • Five (5) to ten (10) years working in pharmaceutical manufacturing and/or experience working with engineering systems and/or Clinical Trials distribution process
  • Deep expertise in project management, especially quality compliance aspects
  • Understanding/experience with ICH Q9 and/or Lilly's Quality Risk Management standards
  • Proven ability to influence globally diverse groups and to effectively manage relationships


• This position is a designated flexible work position in line with Manufacturing and Quality guidelines of 2-4 days working from home monthly.

25-30% to travel to regional distribution centers under NALO Quality oversight

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.

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.

#WeAreLilly

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