Regional Head of Quality Control US

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 playa 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 oftheRegional Technical Operations Leadership Team.

Your role

Implement global policies and oversee the performance of QC in the US, managing a growing teamresponsible 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.

Who are you?

Academical working and thinking level and minimum 10 to 15 years ofrelevant experience in a production environment within Laboratory and Quality Compliance roles within Biotechnology/GMP environment, understanding the Cell Therapy, Quality and manufacturing processes.
Experience with equipment setup, qualification, and method transfer processes.
Strong knowledge of quality control principles, methodologies, and regulatory requirements.
Previous experience with decentralized manufacturing models or CAR-T models is preferred.
Excellent communication, interpersonal, and problem-solving skills.
Ability to effectively manage multiple projects and priorities in a fast-paced environment.

What’s in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

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

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