QA Specialist Quality Oversight
Quality Assurance
Posted on Aug 14, 2026
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.
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, three interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist and the CEO 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 recruitment@hal-allergy.com 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. 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.
