Principal Associate – Quality Auditor

• Schedule, prepare, conduct, and report GQA audits and assessments of internal and external GCP operations
• Assess compliance with company standards, policies, practices, procedures, regulations, and guidelines
• Participate in or lead risk assessments of GCP operations for the risk-based annual audit plan
• Escalate compliance issues appropriately
• Maintain knowledge of applicable regulations, technical requirements, and training standards
• Participate in or lead preparation and review of quality standards, policies, procedures, and guidelines
• Prepare organizational metrics and trend audit findings
• Advise GCP operations on interpreting corporate and regulatory GCP requirements related to quality management
• Complete required training and remain current on industry trends and regulatory interpretations
• Share GCP knowledge with colleagues and support auditor training and qualification
• Participate in or lead divisional improvement efforts, including Six Sigma projects and departmental teams
• Establish effective relationships with internal and external stakeholders

• Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, or another relevant technical area
• Minimum of 5 years of relevant experience within the GCP area at Lilly or within the pharmaceutical environment
• Experience working with third-party organizations
• Ability to understand detailed scientific information while remaining focused on the broader picture
• Ability to interpret and apply regulations, regulatory guidance, codes, public expectations, and compliance changes
• Excellent interpersonal skills and ability to remain constructive and civil in difficult situations
• Ability to deliver timely, precise, and clear oral and written communications to all organizational levels
• Experience working on a global team and sharing knowledge
• Experience with computers and entering data into databases
• Good analytical and problem-solving skills
• Strong communication skills in English, speaking and writing
• Ability to travel domestically and internationally up to 40%, including trips lasting 1–2 weeks and sometimes arranged on short notice
• Business communication skills in Japanese, speaking and writing, are an added advantage
• Ability to manage multiple concurrent tasks and deadlines in a fast-paced environment
• Process perspective and project management skills
• Ability to work independently and collaboratively in a global team environment
• Ability to provide constructive customer feedback and manage change or conflict

• Disability accommodation support during the application process
• Equal opportunity and nondiscrimination commitment
• Professional development through training courses, conferences, or association meetings
• Required role training through the Individual Training Plan (ITP)
• Opportunity to participate in Six Sigma projects and departmental improvement teams