Principal Associate, Medicines Quality (GMQO) - Remote

527 Eli Lilly Cork Limited; Ireland; Remote; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Company bonus

Pension plan

Healthcare benefits

Flexible benefits

Life insurance

Time off and leave

Well-being benefits

Job summary

Lilly is seeking an Associate / Senior Associate / Principal Associate for the Global Medicines Quality Organisation (MQO) Affiliate in Deutschland, with remote work. You will integrate quality requirements into business processes, ensuring consistency between global guidelines and local needs.

This is a 12-month parental leave replacement. You will lead local document control, CAPA, audits, and risk-based advisory across functions while safeguarding sensitive information and collaborating

Qualifications

• Degree in a natural science or health-related field or healthcare profession (e.g., pharmacist, nurse).
• 5–10 years in quality, pharmacovigilance, or regulatory approval areas.
• Experience applying quality systems in regulated environments (GMP, GCP, GVP).
• Strong analytical thinking and risk-based decision making.

Responsibilities

• Develop, review and approve local quality documents, tools and templates.
• Manage deviations, change controls, escalations including root-cause analysis and CAPA.
• Quality oversight for functions: compliance monitoring, trend analyses, recommendations.
• Prepare, coordinate and accompany audits and regulatory inspections, CAPA follow-up.
• First point of contact for quality questions and risk-based advice to functions.
• Share best practices and build cross-functional quality networks; participate in projects.
• Handle sensitive information with confidentiality (patient data, audits, inspections).

Skills

Analytical thinking

Risk-based decision making

Communication skills

Prioritization multitasking

Fluent English and German

Education

Degree in a natural science or health-related field or healthcare profession

Tools

GMP

GCP

GVP

Job description

Lilly is seeking an Associate / Senior Associate / Principal Associate for the Global Medicines Quality Organisation (MQO) Affiliate in Deutschland, with remote work. You will integrate quality requirements into business processes, ensuring consistency between global guidelines and local needs.

This is a 12-month parental leave replacement. You will lead local document control, CAPA, audits, and risk-based advisory across functions while safeguarding sensitive information and collaborating