Associate Vice President - Visual Inspection SME - MSAT

Associate Vice President - Technical Services/Manufacturing Science – Visual Inspection

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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 put people first and are looking for people who are determined to make life better for people around the world.

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. You will provide expert guidance on inspection methodologies, lead training programs, optimize systems, harmonize 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. The ideal candidate will possess deep technical knowledge, people leadership skills, strong analytical abilities, and a commitment to product quality and patient safety. This role will provide leadership for an experienced team of scientists and engineers.

• Visual Inspection Program Development:
  Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring regulatory compliance and industry best practices.
• Talent and culture:
  Build the organization for success; recruit strong talent, manage performance, and foster a culture of innovation, inclusion, and respect for people.
• Process evaluation:
  Evaluate and validate visual inspection processes, including manual and automated methods, to achieve optimal quality outcomes.
• Inspection strategy:
  Establish risk-based inspection strategies for different parenteral products and materials (e.g., vials, syringes).
• Harmonization:
  Harmonize visual inspection control strategies 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.
• CAPA & analytics:
  Conduct root cause analyses and implement corrective and preventive actions for quality events.
• Cross-functional collaboration:
  
  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 global regulatory standards by keeping inspection processes and documentation up-to-date.
• Audits:
  Participate in internal and external audits, providing insights and support for inspection-related findings.
• Documentation leadership:
  Develop and maintain internal strategy and execution documents (validation reports, etc.) to support visual inspection programs.

• Innovation & Continuous Improvement:
  Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency.
• Automation opportunities:
  Identify opportunities for process automation and work with engineering teams to implement new tools and technologies.

• 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.

• 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…