Regional Head of Quality Control US - Galapagos

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

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

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 now looking for a Head of Quality Control for our organization in the US. In this role, you play a crucial role in upholding the highest standards of quality and compliance across our decentralized manufacturing operations. Reporting to the Head of Technical Operations US, you are responsible for overseeing the implementation of global quality control policies within the region, including equipment setup and qualification, method transfer, training and support for clinical manufacturing activities. This role requires strategic thinking, strong leadership skills, and a deep understanding of quality control principles within the pharmaceutical industry. You will also be part of the Regional Technical Operations Leadership Team. 

Your role

Implement global policies and oversee the performance of QC in the US, managing a growing team responsible for:

• Implementation of Global QC Policies:
  • Lead the implementation of global quality control policies and procedures within the US, ensuring alignment with company objectives and regulatory requirements.
  • Collaborate with global quality control team to ensure consistency and standardization of quality control practices across decentralized manufacturing sites.

• Equipment Setup and Qualification:
  • Oversee the setup, validation, and qualification of quality control equipment at decentralized manufacturing sites within the US.
  • Ensure that equipment qualification activities are conducted according to established protocols and regulatory guidelines.

• Method Transfer in Region:
  • Manage the transfer of analytical methods between decentralized manufacturing sites, ensuring accuracy, reliability, and compliance with regulatory standards.
  • Work closely with cross-functional teams to facilitate seamless method transfer processes, training of personnel on the analytical methods and ensure successful implementation.

• Support and Oversight of Clinical Manufacturing:
  • Provide quality control support and oversight for clinical manufacturing activities within the region, ensuring product quality and compliance with regulatory requirements.
  • Collaborate with clinical manufacturing teams to identify and address quality-related issues and implement corrective actions as needed.

• Budget Management:
  • Take responsibility for managing the budget for quality control operations in the US, including the cost of labor, equipment, and supplies.
  • Develop and oversee the budgeting process, ensuring alignment with business goals and objectives.
  • Monitor and track expenses, identify areas for cost savings, and implement measures to optimize spending.