Sr. Principal Associate - Global Compendial Affairs

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.

Key Objectives/Deliverables:  

The global compendial affairs associate will be a part of the Global Quality Analytical Sciences and Quality Control Operations (AQCO) organization and will work with compendial and regulatory affairs colleagues to provide global support to Quality Control Laboratories to maintain compliance with compendial requirements.  Good communication with all global Lilly sites of proposals, changes, issues, publication and implementation of compendial requirements is required.  The role has an additional specialized focus on the management of specification and method compliance to global pharmacopoeias relating to excipients and raw materials.  The position provides technical support and troubleshooting for testing of these materials. 

• The individual in this role will be a compendial coordinator of global Pharmacopoeias (e.g., JP, PhEur, USP) and:  

• Monitor proposed changes to pharmacopoeia requirements and identify those which affect Lilly products, sites, and practices, summarizing issues for affected areas. 

• Provide timely evaluation and technical impact assessment of proposed changes working with site contacts and SMEs. 

• Expertly utilize the application used to perform activities associated with this role (MetricStream RCM). 

• Escalate high impact issues to management. 

• Support coordination of responses to pharmacopoeias. 

• Track publication of official changes. 

• Drive implementation of high impact global compendia changes. 

• Follow-up on internal compliance issues related to compendia changes. Ensure review of proposals by affected areas and technical experts. 

• Lead compendial communication updates with AQCO Global Compendial Affairs, Lilly sites and affiliates, monthly, to ensure Lilly products and practices meet global compendial requirements. 

• Represent Lilly interests to pharmacopoeias and related external industry groups. Utilizing comments from SMEs, prepare scientifically sound and persuasive responses to proposals and submit to pharmacopoeias. 

• Communicate compendial issues within Lilly: Identify issues affecting Lilly items and sites, communicate summaries of issues to affected areas. 

• Provide technical oversight to support Lilly implementation of compendia requirements for excipient and raw material tests. 

• Assist global QC Laboratories on troubleshootin