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.
Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.
The Quality Assurance Commercialization Lead is primarily responsible for QA oversight for commercialization of the parenteral product portfolio within DPEM. The QA Lead will represent DPEM QA on the CMC teams, providing oversight for technology transfers, process validations, regulatory submissions, Response to Questions and launch of new products from DPEM Contract Manufacturers.Responsibilities:
Product and DPEM Support: