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 worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We are committed to putting people first and delivering our best effort.
We are seeking a Quality Assurance professional with experience in drug product manufacturing and batch disposition. The role involves responsibilities related to the start-up of new External Manufacturing relationships, support for existing relationships and products, and ensuring quality standards are met across all activities.
Main Responsibilities
The successful candidate will act as the primary Lilly quality contact for:
* Providing quality support for existing products and external manufacturers (EMs).
* Ensuring EMs follow appropriate quality systems, including change control and deviation management, through visits, communication, and performance monitoring.
* Building and maintaining effective communication with EMs, reporting issues and progress to management.
* Visiting EMs regularly to review operations and produce visit reports.
* Executing quality systems tasks such as batch dispositions, deviation and change control evaluations, and product quality investigations.
* Managing laboratory accreditation processes and analytical method transfers.
* Participating in product reviews, stability programs, and quality evaluations.
* Monitoring supply chains, vendor approvals, and conducting vendor audits.
* Reviewing and maintaining product specifications, quality agreements, and master batch records.
* Identifying and leading quality improvement initiatives, managing corrective actions, and ensuring compliance with technical and regulatory requirements.
* Collaborating with local affiliates and participating in performance reviews, audits, and joint teams.
* Supporting commercialization activities for new products and capacity expansion at EMs.
This role requires proactive engagement in quality assurance activities, collaboration with cross-functional teams, and a strong focus on compliance and continuous improvement.
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