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QC Sample Management Lead
Functieomschrijving
QC Sample Management Lead
General information
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.
Your tasks
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
You have
- 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
Who are we looking for?
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.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient's well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary
- 30 leave days.
- Company contribution to a pension package and health insurance.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via to enquire about a potential recruitment or search agreement with HAL Allergy.
HAL Allergy, for those who seek pharmaceutical innovation
HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!
HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health.Vacaturekenmerken
- Plaats
- Leiden
- Werkgever
- HAL Allergy
- Gemeente
- LEIDEN
- Functiegroep
- Overig
- Branche
- Farmacie
- Provincie
- Zuid-Holland
- Uren
- Fulltime
- Dienstverband
- Vast
- Opleidingsniveau
- HBO