Job Description

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. **Associate Vice President, Visual Inspection TSMS** **Job Summary** : We are seeking a highly skilled Visual Inspection technical leader specializing in parenteral pharmaceutical products. As the visual inspection leader, you will be responsible for building and leading our visual inspection team, program, and processes across a global manufacturing network to ensure the highest quality standards. Your team will provide expert guidance on inspection methodologies, lead training programs, optimize systems, lead harmonization of visual inspection control strategies across the internal and external manufacturing network and drive compliance with regulatory requirements. This role will have accountability for the visual inspection scientists, engineers, and the visual inspection laboratory. Additionally, the ideal candidate will possess deep technical knowledge, people leadership skills, strong analytical skills, and a commitment to product quality and patient safety. This role will provide leadership for an experienced team of scientists and engineers/ **Key Responsibilities** : **Visual Inspection Program Development** : + Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices. + Build the organization for success; Recruit strong talent with the right capabilities, effectively manage performance to elevate team member contributions, and foster a culture of innovation, inclusion, and respect for people. + Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes. + Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes). + Harmonize visual inspection control strategies and practices across the internal and external manufacturing network. **Technical Expertise & Process Optimization** : + Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines. + Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events. + Collaborate with cross-functional teams to identify and implement process improvements that enhance efficiency and reduce inspection errors. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date + Participate in internal and external audits, providing expert insights and support for any inspection-related findings. + Act as subject matter expert for the development and maintenance of internal strategy documents and execution documents (validation reports, etc.) to support the visual inspection programs. **Innovation & Continuous Improvement** : + Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency. + Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies. **Qualifications** : + Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related field. Advanced degree preferred. + 15+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment. **Additional Skills/Preferences:** + In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products. + Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections. + Proven track record of developing training programs and mentoring inspection teams. + Strong analytical and problem-solving skills, with attention to detail and a commitment to quality. + Experience with automated inspection systems and/or artificial intelligence for quality control is a plus. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $202,500 - $343,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. \#WeAreLilly

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Full time, Flexible hours,

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