GxP QA & Compliance Lead

HAL Allergy Group

Netherlands

Remote

EUR 65,000 - 90,000

Full time

13 days ago

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Benefits offered by this job

30 leave days
Pension plan
Health insurance

Job summary

HAL Allergy Group is seeking a QA Specialist Quality Oversight to maintain and improve the QMS, ensuring GMP and GDP compliance across the organization and affiliates. You will support inspections, manage deviations, CAPAs, and change controls, and drive quality culture through audits and training.

The role requires a scientific or life sciences background, auditing experience, and strong communication in Dutch and English. Leiden HQ, competitive salary, and pension/health benefits are offered.

Qualifications

  • Experience with quality systems to ensure compliance across GMP/GDP.
  • Auditing experience including deviations, CAPA, and change control processes.
  • Strong communication skills in Dutch and English; GxP terminology familiarity.

Responsibilities

  • Maintain a robust, inspection-ready QMS across the organization and affiliates.
  • Manage quality records and processes including deviations, CAPAs, and change controls.
  • Coordinate and support QMRs with preparation, reporting and follow-up actions.
  • Develop and oversee audit programs using a risk-based approach; lead audits.
  • Ensure effective follow-up of audit findings and regulatory inspections readiness.
  • Monitor quality KPIs and provide performance insights to management.
  • Act as a quality partner for affiliates and align local QMS with regulatory requirements.
  • Deliver training on GDP, quality systems, and quality topics.
  • Draft and maintain quality procedures, policies, and standards.
  • Represent QA in cross-functional projects and continuous improvement initiatives.

Skills

Quality oversight
Auditing coordination
Regulatory knowledge
Stakeholder communication

Education

Bachelor's degree in scientific or life sciences

Job description

HAL Allergy Group is seeking a QA Specialist Quality Oversight to maintain and improve the QMS, ensuring GMP and GDP compliance across the organization and affiliates. You will support inspections, manage deviations, CAPAs, and change controls, and drive quality culture through audits and training.

The role requires a scientific or life sciences background, auditing experience, and strong communication in Dutch and English. Leiden HQ, competitive salary, and pension/health benefits are offered.

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