End-to-End QC Sample Management Lead

Moderna Therapeutics; Madrid; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family building benefits

Generous paid time off

Job summary

Moderna in Madrid seeks a hands-on Sample Management SME to own end-to-end QC sample workflows across Chemistry, Microbiology and Bioassay. You’ll coordinate with QC labs, External QC, Regulatory, Operations, Manufacturing, QA, Supply Chain and CMOs to ensure compliant, timely sample handling.

You’ll implement SOPs, maintain quality records, support audits, and drive digital initiatives with LIMS and AI tools while ensuring cGMP compliance and a safe, collaborative working environment at the

Qualifications

• Minimum: BA/BSc in a relevant scientific discipline.
• At least 5 years in Quality Control in a cGMP organization.
• Strong working experience in a GMP environment.
• Working knowledge of FDA, EU, ICH guidelines and regulations.

Responsibilities

• Define, implement and maintain an end-to-end sample management process for QC Chemistry, Microbiology and Bioassay samples.
• Serve as a subject matter expert for Sample Management across cross-functional teams to align priorities and timelines.
• Coordinate and facilitate cross-functional resolution of sample management issues with stakeholders.
• Monitor daily sample processing activities and ensure quality records are completed accurately.
• Author and revise SOPs, protocols and quality system records including deviations and CAPAs.
• Create weekly sample management schedules and align with internal and external partners.
• Partner with Digital team to expand LIMS use and explore Generative AI opportunities for QC workflows.
• Work closely with QC laboratories to improve quality, compliance and efficiency of sample operations.
• Provide support to audit teams during internal and external audits.
• Perform general laboratory support and manage controlled-temperature units.

Skills

Quality Control

cGMP

GxP

English Proficiency

Cross-functional collaboration

Education

BA/BSc in a relevant scientific discipline

Tools

LIMS

Generative AI tools

Job description

Moderna in Madrid seeks a hands-on Sample Management SME to own end-to-end QC sample workflows across Chemistry, Microbiology and Bioassay. You’ll coordinate with QC labs, External QC, Regulatory, Operations, Manufacturing, QA, Supply Chain and CMOs to ensure compliant, timely sample handling.

You’ll implement SOPs, maintain quality records, support audits, and drive digital initiatives with LIMS and AI tools while ensuring cGMP compliance and a safe, collaborative working environment at the