QA for DMUs, Senior Specialist - 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 Netherlands , we are looking for a QA for DMUs, Senior Specialist (Decentralized Manufacturing Units) to join us in setting up, promoting and maintaining our QA model.

Scope of the role

As the QA for DMUs, Senior Specialist, you provide quality oversight for DMUs. Your tasks include reviewing and approving records, managing deviations and CAPAs, among other responsibilities. You ensure that technology transfer and monitoring activities at the DMU are performed according to cGMP and Galapagos internal policies. In your role, you will support the improvement of compliance levels at DMUs and Galapagos, helping to shape the quality culture of the organization.

Your role

Responsible for the below related to QA Technology Transfer to the DMUs. This includes:

• Manage DMU user accounts
• Review DMU training records
• Review tech transfer records, such as protocols and reports
• Support documentation management related to tech transfer activities
• Support tech transfer batch records review

Responsibilities related to DMU Supplier Management Oversight:

• Support the onboarding process of new DMUs
• Maintain an overview of DMU qualifications
• Handle DMU change notifications and IA-DMUs
• Create and manage DMU audit records, CAPA plans, and follow up on CAPA implementation
• Manage questionnaires
• Maintain quality agreements with DMUs

Manage DMU Performance Quality Oversight:

• Manage deviations, change control (CC), and CAPA related to tech transfer and DMU monitoring
• Execute DMU monitoring activities to increase compliance levels
• Conduct data integrity risk assessments and define controls and mitigations specific to DMUs

This QA for DMUs, interacts frequently with colleagues from Site Management Cell Therapy, DMU operations, QC Cell Therapy, and Systems and Technology.

• You have a relevant Bachelor’s degree.
• You enjoy working in a fast-paced environment with minimal direction and can adjust your workload based on changing priorities.
• You possess a result-driven and can-do mindset, without compromising quality and compliance.
• Your interpersonal skills enable to align cross-functionally with internal and external stakeholders.
• You have 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 possess a result-driven and can-do mindset, without compromising quality and compliance.
• You are an independent thinker and resourceful.

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 Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!