Global Compendial Affairs Associate

Position Overview

The Global Compendial Affairs Associate will be a part of the Global Quality Analytical Sciences and Quality Control Operations (AQCO) organization. This role provides global support to Quality Control Laboratories to maintain compliance with compendial requirements. The position requires good communication with all global Lilly sites regarding proposals, changes, issues, publications, and implementation of compendial requirements. A specialized focus is placed on managing specification and method compliance to global pharmacopoeias for excipients and raw materials, including providing technical support and troubleshooting for testing of these materials.

Key Objectives & Responsibilities

The individual in this role will act as a compendial coordinator for global Pharmacopoeias (e.g., JP, PhEur, USP) and will:

• Monitor and Assess Pharmacopoeial Changes:
  • Monitor proposed changes to pharmacopoeia requirements and identify those affecting Lilly products, sites, and practices.
  • Summarize issues for affected areas.
  • Provide timely evaluation and technical impact assessment of proposed changes, working with site contacts and Subject Matter Experts (SMEs).
• Manage Compendial Compliance:
  • Expertly utilize the MetricStream RCM application for associated activities.
  • Escalate high-impact issues to management.
  • Support the coordination of responses to pharmacopoeias.
  • Track the publication of official changes.
  • Drive the 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.
• Global Communication and Representation:
  • 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.
  • Prepare scientifically sound and persuasive responses to proposals using comments from SMEs and submit them to pharmacopoeias.
• Internal Communication and Technical Support:
  • Identify issues affecting Lilly items and sites and communicate summaries to affected areas.
  • Provide technical oversight to support Lilly's implementation of compendia requirements for excipient and raw material tests.
  • Assist global QC Laboratories with troubleshooting compendia tests and understanding proposed/revised compendial content.
• Specification and Method Harmonization:
  • Manage global specification information.
  • Support QC Laboratories by authoring/revising Global Method Harmonization Reports (GMHRs) 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 the impact of compendia changes on GMHRs.
  • Maintain reports and manage documentation revision processes.
  • Gather information on the use of the GMHR process to assess effectiveness and facilitate broader global use to produce significant savings in lab resources.
• Support and Improvement:
  • Support Analytical Instrument Qualification (AIQ) efforts as a compendial SME for Global Qualification Harmonization Reports (GQHRs).
  • Support the use and continued improvement of the IT system for compendial surveillance (e.g., MetricStream).

Requirements

• Education: Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy, or Pharmaceutical Sciences.

Company Information

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.

Employment Type

Full time

Location Type

Information not provided.

Salary

Information not provided.