Associate / Senior Associate / Principal Associate – Medicines Quality Organisation

🔥 4 minutes ago

🇮🇪 Ireland – Remote

⏰ Full Time

🟠 Senior

✨ Associate

🗣️🇩🇪 German Required

Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Eli Lilly and Company

Eli Lilly and Company

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

• Support the development, review, and approval of local quality documents, tools, and templates • Manage deviations, change controls, and escalations, including root cause analysis and CAPA • Provide quality oversight for functional areas, including compliance monitoring, trend analysis, and recommendations for action • Prepare, coordinate, and support audits and regulatory inspections, including CAPA follow-up • Serve as the primary point of contact for quality-related questions and provide risk-based advice to functional areas • Share best practices, build a network across quality groups, and contribute to projects • Handle sensitive information, including patient data, audits, and inspections, with the utmost confidentiality • Advise the affiliate and/or region on quality requirements • Integrate quality requirements into business processes and ensure consistency between global standards and local requirements

🎯 Requirements

• Degree in a natural science or health-related discipline, or qualification in a healthcare profession (e.g., pharmacist, nursing professional) • 5–10 years of experience in quality, pharmacovigilance, or regulatory affairs • Practical experience applying quality systems in a regulated environment (GMP, GCP, GVP) • Strong analytical thinking, attention to detail, and risk-based decision-making skills • Persuasive communication skills and the ability to confidently prioritize multiple concurrent tasks • Languages: fluent German and English

🏖️ Benefits

• Eligibility for a company bonus, depending in part on company and individual performance • Eligibility to participate in a pension plan • Vacation benefits • Eligibility for healthcare benefits • Flexible benefits (where applicable) • Life insurance and death benefits • Certain time-off and leave-of-absence benefits • Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities • Full-time employment • 12-month fixed-term parental-leave replacement assignment

Apply Now