QA Specialist

HALIX; Leiden; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive salary

Dynamic work environment

Opportunities for personal development

Job summary

A dynamic biopharmaceutical company located in Leiden is seeking a Quality Assurance (QA) Specialist. This role focuses on maintaining and improving the Quality Management System (QMS) and ensuring compliance with GMP regulations. The ideal candidate will have a Bachelor’s degree in life sciences and at least 5 years of experience in a GMP-CMO environment. Strong communication and technical writing skills are essential for success in this position. A competitive salary and a commitment to continuous improvement in an innovative workspace are offered.

Qualifications

• 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.

Responsibilities

• Implement and improve GMP-compliant quality policies and procedures.
• Serve as an internal QA consultant.
• Coordinate and manage Quality indicators like Deviations and Investigations.

Skills

GMP compliance

Quality Management System (QMS)

Technical writing skills

Lean management

Communication

Education

Bachelor’s degree in life sciences

Job description

Are you passionate about quality, compliance, and making a real impact in the biopharmaceutical industry?

At HALIX, we are looking for a driven Quality Assurance (QA) Specialist who thrives in a dynamic, fast-paced environment and is eager to elevate quality standards across the organization.

In this versatile and influential role, you will be at the heart of our quality operations—ensuring that all products and services consistently meet the highest standards and comply with applicable regulations and industry guidelines. You will play a key role in maintaining and continuously improving our Quality Management System (QMS), ensuring alignment with Good Manufacturing Practice (GMP) requirements and regulatory expectations.

As a QA Specialist, you will collaborate closely with cross-functional teams, actively monitor GMP compliance, and contribute to strengthening a culture where quality is embedded in everything we do. Your expertise will directly support product and process excellence, helping us deliver safe and effective solutions to patients worldwide.

This role is ideal for someone who enjoys variety, takes ownership, and is motivated to drive continuous improvement in a highly regulated, innovative environment.

This position is for 6 months.

• 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.
• Conduct periodic regulatory surveillance.
• Archiving, record keeping and general administration.

You have

• 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.

Who are you?

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 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 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.

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

HALIX 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 [e-mail] to enquire about a potential recruitment or search agreement with HALIX.

HALIX, Bioscience as a Service

HALIX 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 oriented 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.