Quality Assurance Senior Analyst

Job Description : Principal Associate Quality Auditor

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 Overview : The Principal Associate Quality Auditor, part of the Global Quality Auditing and Compliance (GQAAC) division, provides quality assurance through internal and external audits supporting pharmaceutical development, research, product commercialization, pharmacovigilance, and consumer information quality (CIQ). This role ensures GXP operations conducted and sponsored by Lilly comply with company standards, policies, procedures, current regulatory requirements, guidelines, and industry standards.

Key Responsibilities :

• Scheduling, preparing, conducting, and reporting global quality audits and assessments of research and commercial operations, both internally and externally, to evaluate compliance with standards, policies, practices, and regulations.
• Participating in or leading risk assessments of research and commercial operations.
• Revising GQAAC quality system documents and participating in or leading the development of standards, policies, procedures, and guidelines.
• Providing technical expertise and delivering quality and compliance education to relevant stakeholders.
• Maintaining strong interpersonal and communication skills, emphasizing verbal and technical writing skills.
• Completing required training and sharing knowledge through internal meetings, conferences, and associations.
• Leading or participating in divisional improvement efforts, including Six Sigma projects.
• Acting as a proactive coach within the organization, serving as a reference for technical and auditing advice.

Qualifications :

• Experience in auditing (and / or quality) within the pharmaceutical environment.
• Ability to identify and assess risks and impacts, and communicate findings effectively to all levels, including senior management.
• Excellent social skills and the ability to remain constructive in challenging situations.
• Experience working on a global team and sharing knowledge.
• Proficiency with computers and data handling in databases.
• Capability to manage multiple complex projects simultaneously.
• Bachelor's Degree (or equivalent work experience) in physical or biological sciences, engineering, or a related technical field.

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