Remote Medicines Quality Associate (MQO)

Eli Lilly and Company; Kinsale; Remote; EUR 65,000 - 95,000; Full time

Job summary

Lilly is seeking an Associate/ Sr Associate / Principal Associate for the Medicines Quality Organisation (MQO) to join the team in Ireland or remote. You will integrate quality requirements into business processes and ensure consistency between global standards and local needs. This is a 12-month parental leave replacement, full-time.

You will advise on quality matters, support audits, CAPA, and drive continuous improvement across affiliates and regions. Fluent German and English are required.

Qualifications

• Bachelor-level or higher in a natural sciences or health-related field.
• 5–10 years of experience in quality, pharmacovigilance, or regulatory approval.
• Practical use of quality systems in regulated environments (GMP, GCP, GVP).
• Analytical thinking, meticulousness, risk-based decision making.
• Strong communication and ability to prioritize multiple tasks.
• Fluency in German and English.

Responsibilities

• Develop, review and release local quality documents, tools and templates.
• Manage deviations, change controls and escalations including root cause analysis and CAPA.
• Quality oversight for functions: compliance monitoring, trend analyses and action recommendations.
• Prepare, coordinate and accompany audits and regulatory inspections, including CAPA follow-up.
• First point of contact for quality questions and risk-based guidance to functions.
• Share best practices, build a network across quality groups and participate in projects.
• Handle confidential information (patient data, audits, inspections) with care.

Skills

Quality systems GMP/GCP/GVP

Regulatory compliance

Analytical thinking

Communication skills

German/English bilingual

Education

Natural sciences or health-related field degree

Job description

Lilly is seeking an Associate/ Sr Associate / Principal Associate for the Medicines Quality Organisation (MQO) to join the team in Ireland or remote. You will integrate quality requirements into business processes and ensure consistency between global standards and local needs. This is a 12-month parental leave replacement, full-time.

You will advise on quality matters, support audits, CAPA, and drive continuous improvement across affiliates and regions. Fluent German and English are required.