QA Oversight Lead — GMP/GDP Auditor

HAL Allergy Group; Leiden; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

30 leave days

Pension contribution

Health insurance

Job summary

HAL Allergy, headquartered in Leiden, seeks a proactive QA Specialist Quality Oversight to strengthen the QMS and ensure GMP/GDP compliance across the organization and affiliates. You will lead audits, support inspections, and drive continuous improvement within a regulated pharmaceutical environment.

You will partner with stakeholders and external partners to ensure quality culture, readiness, and alignment of local systems with regulatory requirements.

Qualifications

• Bachelor’s degree in a scientific or life sciences field.
• Minimum 2 years of experience in pharmaceutical quality systems (GMP/GDP).
• Auditing experience as a lead auditor.
• Strong knowledge of GMP and GDP requirements.

Responsibilities

• Maintain and improve the Quality Management System (QMS) to ensure compliance and inspection readiness.
• Manage quality records, deviations, CAPAs, and change controls.
• Coordinate Quality Management Reviews (QMRs) including prep, reporting and actions.
• Develop and oversee internal/external audit programs using a risk-based approach.
• Perform audits as lead auditor with effective follow-up of findings.
• Support regulatory inspections and maintain continuous inspection readiness.
• Monitor quality KPIs and provide insights to management.
• Partner with affiliates to 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.

Skills

Quality systems

Auditing

Regulatory compliance

Dutch & English

Education

Bachelor's degree in life sciences

Job description

HAL Allergy, headquartered in Leiden, seeks a proactive QA Specialist Quality Oversight to strengthen the QMS and ensure GMP/GDP compliance across the organization and affiliates. You will lead audits, support inspections, and drive continuous improvement within a regulated pharmaceutical environment.

You will partner with stakeholders and external partners to ensure quality culture, readiness, and alignment of local systems with regulatory requirements.