The Quality Assurance (QA) Specialist is a broad and impactful role responsible for QA operations, quality systems, and regulatory compliance within HALIX. In this position, you will help ensure that all products manufactured and services provided meet the required quality standards in accordance with applicable regulations and industry guidelines.
The QA Specialist plays a key role in maintaining and continuously improving the Quality Management System (QMS) at HALIX, ensuring alignment with relevant Good Manufacturing Practice (GMP) rules and regulatory expectations. You will actively monitor and support GMP compliance throughout the organization and contribute to fostering a strong quality culture.
This is a dynamic position suited for someone who thrives in a high-quality, fast-paced biopharmaceutical environment and enjoys working across multiple teams to ensure product and process excellence.
This position is for 6 months.
Your tasks- Implement and continuously improve GMP‑compliant quality policies, procedures, and instructions to strengthen the HALIX Quality Management System (QMS).
- Serve as an internal QA consultant, translating regulatory requirements and industry standards into practical, day‑to‑day operations across the organization.
- Coordinate and manage Quality indicators—including Deviations, Investigations, Changes, and CAPAs—ensuring timely follow‑up, documentation, and closure.
- Prepare and present Quality Management Review (QMR) reports to provide transparency on quality performance and drive strategic improvements.
- Author, review, and approve quality documentation, including policies, SOPs, work instructions, specifications, and validation‑related documents.
- Lead Supplier Qualification and Supplier Management activities, ensuring suppliers and service providers meet HALIX’s quality and compliance standards.
- Plan, execute, and report on internal audits and self‑inspections, serve as lead auditor, and monitor the completion of related corrections and CAPAs.
- Deliver training and guidance on GMP and quality topics to support competency building within both the QA team and the wider HALIX organization.
- Act as QA Lead for cross‑functional project teams, overseeing GMP compliance in manufacturing processes, batch documentation, and project deliverables.
- Engage directly with customers on quality‑related topics, ensuring clear communication, alignment, and timely resolution of quality matters.
- Conducting periodic regulatory surveillance
- Archiving, record keeping and general administration
- Bachelor’s degree in life sciences (Biotechnology or related) or comparable level through experience.
- Minimum of 5 years working experience within a GMP‑CMO environment.
- Hands on experience in pharmaceutical operations or a laboratory.
- Sound knowledge of European rules and regulations on GMP.
- Preferably knowledge of US rules and regulations on cGMP.
- At least 2 years in depth experience with pharmaceutical quality management systems and compliance projects.
- Preferably experience with Lean management and 6 Sigma methodology.
- Good command of the English language, both verbally and in writing. Fluency in Dutch is beneficial, but not mandatory.
- Excellent technical writing skills.
In this role, you bring not only your technical expertise but also a strong professional mindset. You are committed to ongoing self‑development, actively seeking opportunities to grow and stay current within your field. You work in a result‑oriented way, taking accountability for your decisions, actions, and deliverables.
Collaboration comes naturally to you: you value cooperation and build constructive relationships across teams and with external partners. You demonstrate strong customer focus, ensuring that the needs of clients and stakeholders are clearly understood and consistently met.
In a dynamic GMP environment, you show adaptability, remaining effective when priorities shift or new challenges arise. You also excel in planning and organizing, managing your work efficiently while maintaining high quality standards.
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 close and transparent communication. 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.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
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 agenciesHALIX 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 HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a ServiceHALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service orientated way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX 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. HALIX 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.
#J-18808-Ljbffr€55000 - €75000 monthly