Quality Assurance - External Manufacturing Compliance - Documentation Management

Role: QA Representative in External Manufacturing Quality Assurance, focusing on document management and data integrity to ensure compliance with GMP standards. Core responsibilities include overseeing document systems for Drug Product, Dry, and API external manufacturing, acting as liaison with Learning & Development, leading global initiatives, and supporting audit readiness and system improvements. Responsibilities also encompass training delivery, system audit trail reviews, escalation of compliance issues, and supporting outsourcing activities. Requirements: Bachelor's in science (Engineering, Pharmacy, Chemistry, Biological Sciences); 2+ years in GMP-regulated pharma, with experience in document control or quality systems; authorized to work in the US. Preferred skills: proficiency in computer systems, experience with Lilly systems (Trackwise, QDocs, ServiceNow, SuccessFactors), strong communication, teamwork, and attention to detail, with an improvement mindset. High-Value: role centered on documentation and compliance within Lilly's external manufacturing operations, supporting global quality standards, with some travel expected. Work setup: day shift, with potential off-hours for operational support.