Global Quality Systems Lead — Hybrid

Lilly; Kinsale; Hybrid; EUR 57,000 - 147,000; Full time

Benefits offered by this job

401(k) plan and pension

Job summary

Lilly seeks a seasoned Quality leader with a strong cGMP background to oversee global quality system processes and drive governance across the Operational Controls pillar. This hybrid role requires partnering with manufacturing, external suppliers, R&D, and other functions to implement improvements and ensure compliance.

Qualified candidates have 7+ years in cGMP, a scientific degree, and fluent English. Occasional site visits and international collaboration are expected.

Qualifications

• Bachelor's degree or equivalent in a scientific field, engineering, or related discipline.
• Minimum of 7 years of direct cGMP experience.
• Experience in at least one relevant area or modality (Quality Control labs, cell and gene therapy, or parenteral manufacturing).
• Fluent in English; additional languages preferred.

Responsibilities

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for interpretation, implementation, review, and approval of global quality system processes and documents.
• Lead and improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar to support timely decisions and QMS health.
• Assess, develop, and implement global quality system improvements, including standards, practices, training, tools, and performance insights.
• Partner across manufacturing, external suppliers, marketing affiliate quality operations, R&D, Clinical Supply, and other functions to manage process risks and enable standardized global business processes.
• Monitor regulatory developments, support inspection readiness, and engage with external organizations to maintain compliance.

Skills

Quality governance

cGMP knowledge

Quality risk management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Job description

Lilly seeks a seasoned Quality leader with a strong cGMP background to oversee global quality system processes and drive governance across the Operational Controls pillar. This hybrid role requires partnering with manufacturing, external suppliers, R&D, and other functions to implement improvements and ensure compliance.

Qualified candidates have 7+ years in cGMP, a scientific degree, and fluent English. Occasional site visits and international collaboration are expected.