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 troubleshooting of compendia tests and understanding proposed/revised compendial content. 

Manage global specification information.  

Support QC Laboratories by authoring/revising Global Method Harmonization Reports (GMHR) through technical review of excipient and raw material testing per compendia: 

Write or review technical reports evaluating tests between pharmacopoeias to identify redundant testing and recommend tests and specifications to follow. 

Evaluate impact to GMHRs due to compendia changes. 

Maintain reports and manage documentation revision processes. 

Gather information on use of GMHR process to assess effectiveness and facilitate broader use of GMHRs globally to produce significant savings in lab resources. 

Support Analytical Instrument Qualification (AIQ) efforts as a compendial SME for Global Qualification Harmonization Reports (GQHRs). 

Support use and continued improvement of the IT system for compendial surveillance (e.g., MetricStream). 

Basic Qualifications 

Education:  

Bachelor’s or Master's degree in Biology, Chemistry, Biochemistry, Pharmacy, Pharmaceutical Science, or related field. 

Experience:  

7 or more years of experience in pharmaceutical industry   

Strong technical knowledge of analytical testing methods for raw materials and excipients.   

Strong negotiation skills and experience with national agencies  

Ability to interact with global government agencies and governing bodies 

Strong knowledge of pharmacopoeias. 

Strong knowledge of cGMP's, quality systems, and other regulatory requirements.  

Experience working within a GMP Analytical laboratory.      

Project management skills/ability to maintain, coordinate and communicate schedules and meet milestones and deadlines 

Additional Skills/ Preferences 

Lab testing of excipient and/or raw materials experience. 

Excellent verbal and written communication skills 

Excellent skills with Microsoft applications (e.g., Excel, Word) 

Experience with change management 

Experience with Veeva Quality Docs, MetricStream, OneQMS, and TrackWise applications. 

 Other Information 

This role may involve travel to compendial-related events and other Lilly sites 

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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

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.

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