Manager Global QC Lab 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’.

We are looking for a highly motivated Manager to lead one of our QC Lab Operations teams in Leiden (the Netherlands).

Scope of the job

The QC Lab Operations team is responsible for the routine testing of our products and incoming goods, supporting stability studies, supporting environmental monitoring activities as well as executing method validations. In this role, you are responsible for managing one of the QC Lab Operations teams and their activities while having an active role in the design and implementation of new processes and ensuring GMP compliance.

Your role

• Coordinate and oversee the QC Lab Operations team activities in close collaboration with the other QC Lab Operations Manager and Team Lead

• Develop and manage a work plan for the team based on ongoing activities and priorities

• Responsible for ensuring timely analysis and review of product and incoming goods samples

• Responsible for ensuring adherence to GMP and Data Integrity requirements

• Collaborate and coordinate with other departments to manage workload and priorities

• Design and lead the implementation of new processes and systems

• Review and approve procedures, protocols and reports

• Write and review documentation related to the QC Lab Operations processes

• Lead, perform and review compliance related topics; deviations, CAPAs, change controls, …

• Lead and support lab investigations

• Create and manage the team’s training records

• Onboarding of new team members

Coordinate and oversee the QC Lab Operations team activities in close collaboration with the other QC Lab Operations Manager and Team Lead

Develop and manage a work plan for the team based on ongoing activities and priorities

Responsible for ensuring timely analysis and review of product and incoming goods samples

Responsible for ensuring adherence to GMP and Data Integrity requirements

Collaborate and coordinate with other departments to manage workload and priorities

Design and lead the implementation of new processes and systems

Review and approve procedures, protocols and reports

Write and review documentation related to the QC Lab Operations processes

Lead, perform and review compliance related topics; deviations, CAPAs, change controls, …

Lead and support lab investigations

Create and manage the team’s training records

Onboarding of new team members