Sr Principal Engineer - Global Quality Systems FUME

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 35,000 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 GQS FUME and Distribution Standard Owner provides a variety of activities in support of the Global Engineering and Distribution networks.  As a global expert, they establish and maintain quality standards, business processes and IT tools related to physical assets and the distribution of finished products.  The role partners with the sites and the global engineering and supply chain organizations to assure requirements are well understood and appropriately implemented. 

The role also proactively ensures compliance of Lilly's Quality Systems with various country agency standards, industry trends and scientific principles to assure that all aspects of the operation are in compliance with regulatory expectations and Lilly quality standards.

Key Objectives/Deliverables:

• Standard Owner for 1) the Distribution Quality Standard that governs shipping operations, product protection during shipping, and product shortage prevention, and 2) a number of Engineering Related Quality Standards that govern physical assets (e.g., Facilities, Equipment, Maintenance).
  • Standard ownership involves monitoring and influencing the external environment, identifying trends that warrant standard changes, participating in external forums/committees and engaging in the Lilly network of SMEs on the topic.  The standard owner also completes periodic review for standards to assure they remain current and compliant.
• Drive System Effectiveness:  Establish and maintain relationships within the organization to assure alignment across the sites and functions (engineering, global supply chain, and quality).  The role also consults with and educates customers on quality requirements and champions efficient quality practices. 
• Partner with sites to assure inspection readiness for the applicable quality systems and assist with related responses.  Determine and implement global actions from site inspection observations and trends.
• Drive needed improvements through monitoring of key process indicators across sites, trends, audit and inspection activity, industry practices, and the external environment.
• Provide consulting support to Manufacturing and Distribution operations on interpretation and implementation of Lilly global quality systems.

Basic Qualifications:

• Bachelor’s Degree or equivalent in Engineering or related technical area of study. 
• Strong knowledge of CGMP, GDPs, and quality systems with a minimum of 8 years of direct experience in a pharmaceutical manufacturing setting, including operations, quality, technical services, distribution, or engineering.

Additional Skills/Preferences includes:

• Experience in the following quality systems:
  • Engineering and Maintenance
  • Distribution
• Detailed knowledge of European GMP’s, ICH, PIC/S, US CFR Title 21, US FDA Guidance, and WHO.
• Demonstrated ability to communicate and deliver constructive feedback to global customers, including good oral, written and presentation skills.
• Work in distribution for temperature sensitive materials is beneficial.
• Demonstrated ability to interpret and apply regulatory requirements to different situations by understanding customer needs and applying good problem-solving skills.

Additional Information includes:

• Ability to travel (less than 10%)
• Able to attend training courses, conferences, or association meetings to continue to gain knowledge in GMP, to share such information with other members of the group, or to increase awareness and to train others in the implementation of these practices.
• This is NOT a fully remote role and would require in-person presence at a Lilly site the majority of the time (no less than 3 days per week).

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.

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