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.
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.
- 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 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 LP2
- **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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
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
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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