Position Overview
The Sr. Principal โ Materials and Supplier Management QA provides technical and administrative leadership for materials and supplier quality systems across Lillyโs Advanced Therapies pharmaceutical manufacturing site.
Key Responsibilities
- Lead QA start-up and routine operations overseeing Materials Management and Logistics (supplier governance, warehouse quality support, regulatory compliance).
- Support site QA vision/strategy and foster quality culture; promote teamwork and open communication.
- Support a safe work environment (HSE goals).
- Establish/maintain site material supplier program; maintain approved supplier list, Quality Agreements, risk assessments, and supplier performance reviews.
- Coordinate/write Supplier/Service Provider/Affiliate Quality Agreements; support supplier approval/certification.
- Handle materials/supplier complaints (maintain database; track responses).
- Provide QA support for warehouse/logistics activities (receipt, sampling, testing, approvals); support warehouse qualification.
- Serve as technical SME to review/approve materials management and GMP documentation (qualification docs, change controls, procedures, deviations, specs, quality agreements).
- Perform materials SAP data steward functions; support regulatory inspection readiness.
Basic Requirements
- Bachelorโs in science/engineering/pharma (or equivalent experience).
- 9+ years pharma Quality Assurance, including Materials QA.
- 3+ years managing suppliers/materials in regulated environments.
- 1+ year with SAP or other inventory/material management systems.
- Authorized to work in the US; no visa sponsorship.
Additional Skills/Preferences
- Knowledge of US/EU/Japan regulations; strong communication and technical writing.
- Quality Management Systems/regulatory expertise; prior SAP/Veeva QDocs/TrackWise or similar.
- Train/mentor capability; problem-solving; deviation/change management; start-up and inspection experience.
Location/Work
- Lebanon, IN (LP2); travel 10โ25%; MonโFri, 8โ12 hour days.
Benefits (if eligible)
- 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, well-being benefits.