Lilly Principal Associate -QA CM&C in Indianapolis, Indiana
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 35,000 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.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Position Brand Description :
The primary responsibility of the QA Consultant is to provide and maintain the interface between Product R&D Quality Assurance and Global Regulatory Affairs for CMC (GRACMC).
Ensuring that the internal Material Specification Packages (MSP) are in alignment with all global regulatory documents and commitments.
The consultant will receive study-country regulatory approvals provided from GRACMC or the affiliate sites and respond appropriately to that information. The QA Consultant will have responsibility for maintaining the study-country approval status of materials within the appropriate modules of the ERP system (SAP).
(S)he will be responsible for maintaining country-specific dating information in the shelf life table in the ERP system for applicable drug products for each study.
The Consultant will work directly with Regulatory Affairs to ensure appropriate impact assessments are completed for all Regulatory changes and appropriate implementation steps are completed.
The Consultant will be a key participant with IP Ops teams to understand and support trial timelines, material submissions and approvals, and dating commitments and extensions to prevent negative patient impact.
Among other responsibilities, as assigned:
Provide guidance for CMC &/or IP Ops teams for supported molecules on document needs to permit approval activities in SAP
Ensure that MSPs (Material Specification Packages) are maintained in alignment with all global Regulatory submission documents and commitments.
Work with GRACMC to ensure that a Regulatory Document (RDOC) is created to document the alignment of the MSP and the regulatory documents.
Ensure robust PRD Quality System to enable regulatory compliance processes
Regulatory Commitment Verification Form (RCVF) process:
Receive the RCVF information as provided by affiliate sites.
Populate and maintain the Study-Country Status Management (SCSM) module in SAP with the appropriate regulatory status for each country.
Cascade the country approval status for each material to the relevant batches of the material, as appropriate.
Populate and maintain the shelf life table for each material with any country-specific dating requirements.
Bachelor’s Degree in Chemistry, Biochemistry, Microbiology, Pharmacy, Engineering, or other related science. Work related experience may be substituted.
A minimum of 5 years of industry experience, preferably including QA batch release in a clinical trial environment, regulatory affairs (CMC), or clinical supply/material management
Basic computer skills and soft skills including communication, interpersonal interactions, technical writing, organizing, project management, prioritizing, observation, evaluation, problem-solving, and decision making.
Knowledge of corporate policies and procedures, SOPs, and cGMPs, GQS and regulatory requirements
Knowledge of and user-skills related to Trackwise and SAP
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).