Associate Director

3 weeks ago

Indianapolis, Indiana, United States Eli Lilly and Company Full time

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.

About POINT Biopharma:

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT is a wholly owned subsidiary of Eli Lilly and Company.

Position Summary:

The Associate Director of Quality Engineering and Computer System Validation (CSV) is responsible for overseeing the continued development, improvement, execution, and oversight of Quality Systems related to POINTs Engineering and Computer System Validation processes. The Associate Director of Engineering and CSV will work across the POINT organization to provide Quality support to all Engineering activities and Computer Systems, including oversight of design/user requirement development and all commissioning/qualification activities for facilities and equipment. This role also provides oversight on ongoing operations of same systems.

Responsibilities: Provide robust organizational leadership to team of associates as well as coaching and development. Partner proactively with colleagues in Operations and Engineering to ensure business targets are met while ensuring facilities, equipment and systems are designed, established, and operated in a GMP manner. Overall accountability for Quality oversight of facility and equipment commissioning, qualification, and validation Accountability to ensure that changes to facilities and equipment are appropriately managed through the Change Management system. Collaborate with senior leadership team in meeting organizational goals through establishment and reporting of metrics. Act as subject matter expert to peers, colleagues, and staff Ensure validation master plans and validation protocols are established and executed in a compliant and technically sound manner. Ensure procedures and policies remain current to relevant company and regulatory requirements. Assist in the design of validation plans and protocols. Ensure Engineering Quality oversight of changes and deviations impacting Facilities, Utilities, Maintenance, Engineering and Computer Systems Participate in audits and inspections as needed. Basic Requirements: Minimum BS in Engineering, Science, or Technical Degree required. 10 years' experience in pharmaceutical Quality Engineering or pharmaceutical manufacturing quality oversight required. 5 years' experience in organizational leadership Experience participating in GMP regulatory inspections. Hands on experience in authoring, editing, and approving GMP documents (primarily validation, deviation, change) required. Additional Preferences: Demonstrated Project Management skills and ability to coordinate complex projects. Ability to communicate and influence effectively across functional groups and stakeholders. Strategic thinking and ability to balance short term needs with long term business evolution. Experience in developing/implementing quality systems. Additional Information: The physical demands of this job are consistent with an office environment with occasional gowning to be present in an aseptic manufacturing area. Minimal US travel,

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