Senior Principal - Supplier and Material Management QA
Position Overview
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.
Key Responsibilities
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.
Capture and manage supplier and service provider governance.
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, sing, 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).Quality Management
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.
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.
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 decision-making skills.
Strong knowledge of Quality Management Systems and applicable regulatory requirements.
Previous experience with material management computer systems, including SAP, Veeva QDocs, TrackWise, or similar systems.
Demonstrated technical writing skills.
Previous facility or area start-up experience.
Previous regulatory inspection readiness and inspection execution experience.
Previous experience with deviation and change management systems.
Additional Information
Position Location: US: Lebanon IN
Travel Percentage (%): Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish material management system knowledge
Shift Information: Ability to work 8-12 hour days – Monday through Friday at the Lebanon, Indiana gene therapy site
Actual Compensation
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400