Sr Principal Associate - QA Logistics Operations

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.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
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 engineering quality and for quality risk assessment.
The QA Senior Principal Associate with also be a point of contact between the QA and engineering/maintenance and the individual will be expected to make decisions regarding quality within the NALO Quality System.
The QA Senior Principal Associate will drive large-scale quality improvement projects and influence direction for NALO. The position is responsible for ensuring compliance with all GMPs, internal standards and systems, procedures, and guidelines for distribution activities. Specific responsibilities include:
NALO Quality:

• Understand technical engineering concepts and be able to apply Lilly standards to work done within NALO
• 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 Operations organization by:

• Timely and accurate reporting, change controls, action item completion, and investigations
• Collaborate with other functions, including hands-on work experience and shared learning
• Benchmarking with other Lilly sites to gain support for solutions

Basic Qualifications:

• Bachelor's degree in Engineering, Pharmacy or related science degree, or equivalent experience
• Five (5) to ten (10) years working in a biotech (pharmaceutical/medical device) manufacturing environment and/or experience working with engineering systems and/or Clinical Trials distribution process

Additional Skills/Preferences:

• Proven learning agility
• Proven ability to influence globally diverse groups and to effectively manage relationships
• Deep expertise in scientific principles of engineering and maintenance, especially quality compliance aspects
• Experience working in distribution, packaging, and/or with cold chain processes
• Technical knowledge in container qualification
• Understanding/experience with ICH Q9 and/or Lilly's Quality Risk Management standards

Additional Info:
This position is a designated flexible work position in line with Manufacturing and Quality hybrid guidelines of 2-4 days working from home monthly as business need allows.
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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