Sr. Principal Associate QDDA Auditor

Eli Lilly • Indianapolis, IN

375d • $111,000 - $162,800

About The Position

The Sr. Principal Associate - Quality Due Diligence Assessment Auditor (QDDA) is a key role within Lilly's Global Quality Auditing and Compliance (GQAAC) division. This position is responsible for ensuring quality assurance through the execution of internal and external audits related to pharmaceutical development, clinical research, and product commercialization. The auditor will lead audit teams, assess compliance with company standards and regulatory requirements, and contribute to the continuous quality assurance program aimed at enhancing operational quality across Lilly's global operations.

Requirements

• Bachelor's Degree in physical or biological sciences, Engineering or other technical area.
• Minimum 7 years of experience within the relevant GXP area at Lilly or within the pharmaceutical environment.
• Experience working with Third Party Organizations.

Nice To Haves

• Ability to analyze detailed technical scientific information and articulate risk and impact.
• Excellent interpersonal skills and ability to remain constructive in difficult situations.
• Experience with computers and managing data in databases.
• Good analytical/problem-solving skills.
• Proven ability to think and analyze from a process perspective.

Responsibilities

• Schedule, prepare, conduct, and report Global Quality audits and assessments of research and commercial operations.
• Lead audit teams and execute a portfolio of complex audits as lead or solo auditor.
• Participate in mock-inspections and risk assessments of research and commercial operations.
• Drive the escalation of compliance issues or significant risks identified during audits.
• Identify the need and drive the revision of GQAAC quality system documents when appropriate.
• Provide advice on the interpretation of corporate and regulatory GXP requirements.
• Establish and maintain relationships with relevant regulatory authorities.

Benefits

• 401(k) participation
• Pension benefits
• Vacation benefits
• Medical, dental, vision, and prescription drug benefits
• Flexible spending accounts
• Life insurance and death benefits
• Employee assistance program
• Fitness benefits
• Employee clubs and activities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree