Senior Principal - Supplier and Material Management QA

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.

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* Position Overview:

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* The Sr. Principal - Materials and Supplier Management QA provides technical and administrative leadership for materials and supplier quality systems across Lilly's Advanced Therapies pharmaceutical manufacturing site. This role leads the start-up and routine operation of QA functions overseeing Materials Management and Logistics operations, including supplier governance, warehouse quality support, and regulatory compliance. The role partners cross-functionally with supply chain, procurement, customer service, and warehouse operations to ensure materials and suppliers meet Lilly Quality Standards.

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* Key Responsibilities:

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* ** Leadership & Quality Culture*
* + Work with the Associate Director of Quality Assurance to support the development of the vision, strategy, and quality culture for the overall site QA organization, with focus on materials management, supplier and service provider governance, and logistics activities.

+ Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

+ Support a safe work environment, including supporting and leading safety efforts for your team and adhering to HSE corporate and site goals.

** Materials & Supplier Management*
* + Establish and maintain the site material supplier program, partnering with other Lilly manufacturing sites and global materials management teams.

+ Develop and maintain the approved supplier list, Quality Agreements, material and supplier risk assessments, and periodic reviews of supplier performance.

+ Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, ensuring compliance with associated requirements.

+ Provide input, guidance, and recommendations for supplier/service provider approval and certification activities.

+ Responsible for materials and supplier complaint handling; maintain complaint database and track supplier responses.

+ Provide quality assurance support to the warehouse and logistics for all operational needs, including incoming material receipt, sampling, testing, and material approvals.

+ Network with cross-functional resources to ensure establishment of the materials management quality system and facilitate facility (e.g., warehouse) qualification.

+ Serve as technical resource to review and approve materials management documents (e.g., qualification documents, change controls, procedures, quality agreements).

+ Review and approve GMP documentation including procedures, deviations, technical reports, specifications, and change controls.

+ Provide input and guidance for site activities (e.g., new product/process development, tech transfer, change controls) as materials/vendor management quality SME.

+ Perform materials SAP data steward functions.

+ Support regulatory inspection activities by providing documentation, subject matter expertise, and inspection readiness support.

+ Demonstrate knowledge and application of US, EU, Japanese, and other applicable regulations in pharmaceutical manufacturing and material/supplier management.

+ Support development of the overall site operational readiness plan, including development of quality processes and approval of operational procedures and controls.

+ Provide subject matter expertise for material/vendor management quality during new product/process development and technology transfers.

** Basic Requirements:*
* + Bachelor's degree in a science, engineering, or pharmaceutical-related field of study, or equivalent industry experience.

+ 9+ years in pharmaceutical Quality Assurance, including specific Materials QA experience.

+ 3+ years of experience working with and managing suppliers and materials in a regulated environment.

+ 1+ years of experience with SAP or other inventory/material management systems

+ Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

** Additional Skills / Preferences:*
* + Demonstrated knowledge of US, EU, Japanese, and other applicable regulations in pharmaceutical manufacturing and material/supplier management.

+ Excellent interpersonal, written, and oral communication skills.

+ Strong technical aptitude and ability to train and mentor others.

+ Demonstrated problem-solving and…