QA Specialist Quality Oversight

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

General information

QA Specialist Quality Oversight

As QA Specialist Quality Oversight, you play a key role in maintaining and continuously improving our Quality Management System (QMS). You ensure compliance with GMP and GDP regulations, support inspection readiness across the organization and affiliates, and provide expert quality oversight in a regulated pharmaceutical environment. You will work closely with internal stakeholders, external partners, and affiliated companies to strengthen quality culture and drive operational excellence.

Your tasks

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

You have

• Bachelor's degree in a relevant scientific or life sciences discipline.
• Relevant experience within the pharmaceutical industry.
• Experience working with quality systems, including deviations, CAPA management, 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.
• GCP and GVP auditor certification is an advantage.
• GDP Responsible Person certification is an advantage.

Who are we looking for?

You are a proactive and results-oriented quality professional who enjoys collaborating across functions and cultures. You combine strong analytical thinking with a pragmatic approach and can effectively influence stakeholders at different levels of the organization. You demonstrate accountability, adaptability, and a continuous improvement mindset, while maintaining a strong focus on quality and compliance.

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.

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. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. 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. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.