Director– Sterility Assurance

Role Summary

Director– Sterility Assurance. Lead and harmonize Sterility Assurance programs across the Lilly Parenteral Network, providing technical oversight, strategic direction, and collaboration with sites, SMEs, and external partners to ensure alignment with regulatory and quality standards. Support new site design, start-up activities, and regulatory interactions, while building network-level capability in sterility assurance.

Responsibilities

• Assess differences in current sterility assurance programs across sites and drive harmonization
• Work with site and multi-functional SMEs to drive cohesion; ensure control strategies are robust, regulatory compliant, and continuously improved
• Lead specific topics within Sterility Assurance across the network and facilitate knowledge sharing
• Represent TS/MS on governance forums and present sterility assurance programs and learnings to network teams; share best practices across sites
• Mentor site SMEs to build capability, especially at newer sites or where deep expertise is lacking
• Build, maintain, and grow capability across the organization in sterility assurance
• Provide technical support to new sites during design and start-up to meet sterility requirements
• Support significant sterility assurance investigations, identify root causes, and implement CAPAs; share learnings across sites
• Benchmark industry trends and regulatory guidance; advance Lilly’s agenda; engage with external bodies and assess new technologies
• Collaborate with PR&D on new technologies/platforms to ensure manufacturing needs are met and control strategies are fit-for-purpose
• Provide ad-hoc technical support to Lilly organizations outside the Parenteral Network
• Support regulatory interactions such as RtQ submissions and on-site inspections
• Maintain a safe work environment and support HSE corporate goals

Qualifications

• BS Degree required; MS/PhD in a biological science preferred
• 10+ years’ experience in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles
• 10+ years’ experience in parenteral manufacturing sterility assurance control systems
• Deep technical understanding of sterility assurance from science and compliance perspectives; current knowledge of industry developments
• Proficiency in data analysis, prioritization, attention to detail, and complex problem-solving
• Strong written and oral communication skills
• Ability to mentor and develop scientists in sterility assurance and applied pharmaceutical microbiology
• Understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance
• Demonstrated experience influencing site and network leaders to advance technical agenda projects

Skills

• Leadership and mentoring
• Cross-functional collaboration
• Regulatory and quality compliance
• Strategic planning and program harmonization
• Technical acumen in sterility assurance and manufacturing processes
• Communication and stakeholder management

Education

• BS required; advanced degree preferred

Additional Requirements

• Approximately 25% travel