QC Sample Management Lead

Location: Leiden (NL) | Hours: 36-40 per week

This role is based in the Netherlands. Applicants must be eligible to work in the Netherlands.

The QC Sample Management Lead is responsible for the end-to-end coordination, oversight, and continuous improvement of all QC sample management processes. This includes production, development, stability, incoming goods, environmental monitoring, reference materials, and externally tested samples.

You ensure that all samples are handled, stored, processed, and documented in full compliance with GMP and internal procedures. As the subject matter expert (SME) for sample management, external laboratory coordination, and laboratory supplies, you provide functional guidance to the QC team and drive process improvements that enhance efficiency, compliance, and business continuity.

This role does not include line management. In the absence of the Supervisor QC Microbiology & Sample Management, you act as deputy and primary point of contact.

Sample Management & Coordination

• Maintain and oversee the QC sample test plan, including internal and external testing activities
• Coordinate testing priorities with Production, QA, Supply Chain, and other stakeholders
• Manage the full lifecycle of samples: requesting, receiving, processing, distribution, shipping, storage, retrieval, and destruction
• Ensure traceability, chain-of-custody, and compliance at all times
• Manage reference samples, IHRP, standards, and serum supplies
• Ensure correct storage and transport conditions for all sample types

External Laboratory Management

• Provide insight into external laboratory capacity and performance
• Coordinate with external labs on workload, timelines, and progress of analyses
• Monitor delays, initiate corrective actions, and escalate when required
• Process, review, and verify results from external laboratories
• 
  Quality, Compliance & Improvement
• Maintain, improve, and standardize sample management procedures, workflows, and documentation
• Write, review, and follow up on SOPs, deviations (including OOS), CAPAs, and change controls
• Ensure compliance with GMP, EHS, and company policies
• Support investigations, troubleshooting, and root-cause analyses
• Identify process gaps and lead improvement initiatives to increase efficiency and compliance
• Represent QC Sample Management during audits and inspections

Expertise, Communication & Reporting

• Provide training and functional guidance to team members (without line-management responsibility)
• Represent QC Sample Management in cross-functional projects
• Report performance, risks, and improvement progress to QC management
• Act as deputy for the Supervisor QC Microbiology & Sample Management when required
• Act as the primary point of contact for sample-related topics across QC, QA, Production, Supply Chain, and external partners

• HBO level of education (or equivalent)
• Several years of experience in the pharmaceutical and/or biochemistry industry
• Strong knowledge of GMP and QC processes
• Proficient in Dutch and English, both spoken and written
• Strong communication skills across different organizational levels
• Experience with MS Office (advanced Excel), LIMS, ERP, and eQMS systems

You are an experienced QC professional with strong expertise in sample management within a GMP-regulated environment. You have a thorough understanding of QC processes and take ownership of sample flows from receipt to final disposition, ensuring full compliance and traceability.

You act as a subject matter expert and are comfortable coordinating with multiple internal stakeholders and external laboratories. Structured, accurate, and proactive, you identify risks early and drive continuous improvements in processes and documentation.

You communicate clearly at all levels, work independently without line-management responsibility, and provide functional guidance through expertise and collaboration. Reliable and quality-focused, you contribute to business continuity and audit readiness.