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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, <10%.

• This position’s work environment is on-site, in an office environment, with routine presence in manufacturing areas.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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