Manager Quality Assurance

Location: Leiden, The Netherlands | Hours: 40 per week

HAL Allergy is a leading European company in allergy immunotherapy, with a strong international position in the development and production of modified allergen extracts for both therapeutic and diagnostic use. To support our continued growth, we are looking for an experienced Manager Quality Assurance (QA).

As
Manager QA
, managing a QA Systems- and a QA Operational team, you are responsible for developing, implementing, and maintaining a quality policy focused on continuous improvement across the organization. You ensure that quality-driven decision-making is embedded in our processes and that our quality systems remain fully compliant with applicable regulations.

You oversee the batch review and release process for both HAL Allergy products and batches manufactured under our Contract Manufacturing Organization (CMO) activities. In close collaboration with Production, Technical Services, Quality Control (QC), Regulatory Affairs (RA), Qualified Persons (QPs), and Tech Transfer, you ensure the timely delivery of complete and compliant batch documentation to the QPs for final release.

This is a high-impact role in an entrepreneurial environment, where you actively shape our quality strategy. You will have the opportunity to make a real difference as part of the Quality Unit Management Team, together with ESH, Regulatory Affairs, and Quality Control, as well as being a member of the Operational Management Team. If you want to contribute to improving patients' quality of life, we invite you to apply.

Your tasks

• Lead the QA department, coordinating daily activities, setting priorities, and ensuring effective operational management.
• Maintain and continuously improve the Quality Management System (QMS), Document Management System (DMS), and training programs.
• Ensure timely availability of batch documentation to QPs, supporting on-time batch release.
• Implement and maintain programs and processes to ensure high product quality and ongoing compliance with (c)GxP requirements.
• Lead and support regulatory inspections (e.g. IGJ, FDA) and customer audits.
• Ensure inspection and audit observations are addressed appropriately and in a timely manner.
• Maintain a state of continuous inspection readiness and drive continuous quality improvement.
• Provide quality oversight and compliance support to affiliated offices.
• Participate in and lead continuous improvement programs and projects.
• Manage internal and external audit programs and supplier qualification activities.
• Act as lead for investigations and for defining corrective and preventive actions (CAPA) related to product manufacturing, when required.
• Monitor developments in Validation, Document Management, and Quality Systems, and translate these into opportunities and challenges for the organization.
• Define, monitor, and report on quality metrics and KPIs.
• Perform data analysis and trending within the QMS for oversight, reporting, and improvement purposes, and prepare the Quality Management Review.
• Establish and maintain appropriate quality oversight for equipment and computerized systems validation.
• Further develop and actively promote a strong Quality culture and a clear vision on continuous improvement within HAL Allergy.
• Maintain oversight of batch review, quality issues, and product quality complaints.
• Participate in supplier and subcontractor audits when necessary.
• Work closely with Recruitment and HR to attract, develop, and coach qualified QA professionals to achieve their performance goals.

You have

• Master of Science in a relevant scientific discipline.
• At least 10 years of relevant experience in the pharmaceutical industry in a QA role, including a minimum of 5 years in a leadership position.
• Experience with FDA regulations is an advantage.
• Broad experience with quality-related topics in an aseptic manufacturing environment.
• Solid knowledge of pharmaceutical regulations and compliance requirements.
• Excellent command of the English language, both spoken and written; strong proficiency in Dutch is highly preferred.
• Proven experience with audits and regulatory inspections.

Who are we looking for?

You are an entrepreneurial QA leader who thrives in a dynamic organization. You combine a strong quality mindset with a pragmatic, business-oriented approach and are comfortable taking ownership and driving change. You are proactive, decisive, and able to balance compliance with operational and business needs.

You communicate clearly and confidently at all levels of the organization and naturally build strong, trust-based relationships. Collaboration comes naturally to you, and you enjoy working closely with cross-functional teams on-site to achieve shared goals. You have a proven ability to translate complex laws and regulations into practical, scalable processes and inspire your team to continuously raise the quality bar. As a people manager, you develop talent, encourage ownership, and foster a culture of continuous improvement.

You get

• 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 product 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 heath 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, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist 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 - to enquire about a potential recruitment or search agreement with HAL Allergy.

HAL Allergy, for those who seek for 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 HAL 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 part of an innovative and challenging pharmaceutical manufacturer, then this is a 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.