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.
Position: Principal Associate Quality Auditor
This role is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through internal and external audits supporting pharmaceutical development, non-clinical and clinical research, product commercialization, pharmacovigilance, and consumer information quality (CIQ) for Lilly.
The Principal Associate Quality Auditor ensures that GXP operations conducted and sponsored by Lilly comply with company standards, policies, procedures, current regulatory requirements, and industry guidelines.
GQAAC adopts a proactive approach to ensure effective implementation of a continuous quality assurance program, guaranteeing compliance across all Lilly operations and enhancing quality of operations and contracted parties.
Responsibilities include scheduling, preparing, conducting, and reporting on global quality audits and assessments of research and commercial operations, both internally and externally, to assess compliance with standards and regulations.
The role involves participating in or leading risk assessments, maintaining comprehensive knowledge of applicable regulations, and ensuring training requirements are met.
Global Quality – Business Responsibilities
Identify and drive revisions of GQAAC quality system documents, participate in or lead the development of standards, policies, procedures, and guidelines, and provide technical expertise in quality and compliance education.
Maintain strong interpersonal and communication skills, complete required training, and share knowledge through conferences and meetings.
Participate or lead improvement efforts, including Six Sigma projects, and act as a proactive coach within the organization, serving as a reference for technical and auditing advice.
Qualifications include auditing experience in the pharmaceutical environment, ability to assess risks and communicate findings effectively, excellent social skills, and experience working on a global team.
Computer proficiency and the ability to manage multiple complex projects are required.
Bachelor's Degree in physical or biological sciences, engineering, or a related technical field, or equivalent work experience.
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