Director, Parenteral Sterility Assurance

Director, Parenteral Sterility Assurance

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, that works 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.

Lilly is building a stronger Sterility Assurance function to provide increased technical capacity across the network. This role oversees and harmonizes technical programs that govern the implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network, aligns strategies with technical, quality, and regulatory guidance, and supports technical capability development at Lilly sites.

• Assess differences in current sterility assurance programs across sites and drive harmonization.
• Work closely with site and multi‑functional SMEs to ensure control strategies are robust, consistent with regulatory and compliance expectations, and continuously improved.
• Assume SME leadership for a specific topic area within Sterility Assurance, including harmonization and knowledge facilitation across the network.
• Represent TS/MS on network Science Lead Team and other governance forums; present Sterility Assurance programs and best practices to align across sites.
• Provide mentoring leadership to site SMEs to build capability, especially at newer sites or where deep technical expertise is lacking.
• Build, maintain, and grow capability across the organization in the sterility assurance space.
• Provide technical support to new sites or filling lines during design and start‑up activities to ensure sterility assurance programs and process/product requirements are supported at these sites.
• Provide technical support for significant sterility assurance investigations to identify root cause and implement corrective actions; share best practices and CAPAs across sites.
• Benchmark industry trends and emerging regulatory guidance; represent Lilly on relevant external bodies and influence the agenda within PR&D to ensure manufacturing needs are met.
• Engage in regulatory interactions such as RtQ of submissions and on‑site inspections.
• Maintain a safe work environment and support all HSE Corporate Goals.

• BS degree required; MS or 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, including development, execution, operation, and continuous improvement in a highly regulated environment.
• Deep technical understanding of sterility assurance from both science and compliance perspectives; current in technological and compliance developments across the parenteral manufacturing industry.
• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision‑making skills, and complex problem‑solving abilities.
• 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 relating to sterility assurance.
• Demonstrated experience influencing site and network leaders to advance technical agenda projects.

• Work closely with senior technical staff in the parenteral network TSMS group to provide oversight to new and existing facilities and support inspection readiness.
• Support the establishment of a sterility assurance network or hub in global TSMS.
• Support inspection preparation and execution during health authority on‑site or remote inspections.
• Experience leading external committees or conferences to maintain Lilly’s leadership in the sterility assurance space.
• Work with engineering SMEs to support Lilly platforms and maximize performance while minimizing sterility assurance risk.
• Strong capability to influence personnel and management across the organization.
• Close interaction with quality to enable internal audits that identify…