Principal Associate – Quality Auditor
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Job Description
Quality Auditor conducting GCP audits for Lilly’s global pharmaceutical operations. Assessing regulatory compliance and supporting risk-based quality oversight across internal and external operations.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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
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