QA coordinator Operations, Leiden/NL

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

For the Galapagos organization in the Netherland , we are looking for a QA coordinator Operations to join us in setting up, promoting and maintaining the QA model.

Scope

As QA coordinator Operations , you join our Quality Assurance team. We are a growing team, building a QA model for our expanding organization, working closely with the Decentralized Manufacturing Units (DMUs) and our internal partners inside and outside our Quality department. As the central site in this decentralized model, we oversee both central GxP activities, and CAR T-cell manufacturing close to patients. In this rapidly evolving field, we’re building a strong fundament to carry the next steps in the clinical development of current and future products, as well as toward commercial launch.

At Galapagos, we strongly believe in the power of collaboration to achieve ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied.

Your role

Batch Documentation Review

• Review batch manufacturing records and laboratory test results to ensure completeness, accuracy, and compliance with GMP.
• Verify that all critical process steps and quality checks have been properly documented.

Coordination and Communication

• Liaise with production, quality control, and other departments to resolve any issues related to batch release in a timely manner.

Deviation and CAPA Management

• Manage deviations, change control (CC), and CAPA related to batch production and testing.
• Handling of impact assessments related to related to batch release in a timely manner.

Continuous Improvement

• Identify opportunities for improving batch release processes and quality systems.
• Participate in quality improvement initiatives and cross-functional projects.

This position is based in the Finch, our offices at the Leiden Bio Science Park. In this role, you interact frequently with GLPG colleagues from Technical Operations, DMU Operations, QC Cell Therapy, and Systems & Technology.

• A relevant Bachelor’s degree.
• Able to work in a fast-paced medium sized company environment with minimal direction and agile in adjusting workload based on changing priorities.
• Result-driven and can-do mindset, without compromising quality and compliance.
• Well developed interpersonal skills for cross functional alignment with internal and external stakeholders.
• With at least 2 years of experience in a role within a GMP environment with thorough working knowledge of cGMP QA processes: QA management and Good Manufacturing Practices.
• Experience in a commercial GMP manufacturing setting is preferred.
• Experience in an ATMP manufacturing setting is preferred.
• You enjoy working in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.
• Result-driven and can-do mindset, without compromising quality and compliance.
• You are an independent resourceful thinker and take initiatives.
• You are able to travel for on-site visits to DMU sites for F2F interaction with stakeholders.
• Written and spoken fluency in English.
• You enjoy presenting your own work in functional (team or multidisciplinary team) meetings.

What’s in it for you?

You will be part of a fast-growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

We are Galapagos : together we make it happen…!