Quality Oversight Specialist – GMP/GDP Auditor, 13th Month

Qabird; Leiden; On-site; EUR 65,000 - 95,000; Full time

Benefits offered by this job

13th month salary

30 leave days

Company pension

Health insurance

Job summary

HAL Allergy is seeking a QA Specialist Quality Oversight in Leiden to maintain a compliant QMS across our organization and affiliates. You will lead audits, manage deviations and CAPAs, and support regulatory inspections while driving continuous improvement.

The role requires GMP/GDP expertise, auditing credentials, and fluency in Dutch and English. You will collaborate with internal teams and external partners to strengthen quality culture and ensure patient safety.

Qualifications

• Experience with quality systems, deviations, CAPA, and change control processes.
• Strong knowledge of GMP and GDP requirements.
• Certified GMP/GDP auditor with at least two years of internal and external auditing experience.
• Excellent communication skills in Dutch and English.

Responsibilities

• Ensure a robust, compliant, and inspection-ready Quality Management System.
• Manage quality records and processes, including deviations, CAPAs, and change controls.
• Coordinate and support Quality Management Reviews (QMRs), including preparation, reporting, and follow-up actions.
• Develop and oversee internal and external audit programs using a risk-based approach.
• Perform audits as lead auditor and ensure effective follow-up of findings.
• Support regulatory inspections and maintain inspection readiness.
• Monitor and report quality KPIs and provide management with insights.
• Act as a quality partner for affiliates and align local quality systems with regulatory requirements.
• Deliver training on GDP, quality systems, and related topics.
• Draft and maintain quality procedures, policies, and standards.
• Represent QA in cross-functional projects and continuous improvement initiatives.

Skills

Quality systems knowledge

GMP/GDP knowledge

Auditing experience

Dutch-English communication

Education

Bachelor's degree in Life Sciences

Job description

HAL Allergy is seeking a QA Specialist Quality Oversight in Leiden to maintain a compliant QMS across our organization and affiliates. You will lead audits, manage deviations and CAPAs, and support regulatory inspections while driving continuous improvement.

The role requires GMP/GDP expertise, auditing credentials, and fluency in Dutch and English. You will collaborate with internal teams and external partners to strengthen quality culture and ensure patient safety.