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.

• 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.