Principal Associate – Quality Auditor

🔥 7 minutes ago

🇸🇬 Singapore – Remote

⏰ Full Time

🟡 Mid-level

🔎 Auditor

👻 Ghost score 10%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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