QA Operations Specialist - Contractor (6 months), Leiden

Pleased to meet you, we are Galapagos , a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

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.

Join our Quality Assurance team. We are a growing team, building a QA model for our expanding organization, working closely with the Decentralized manufacturing partners 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 changing 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.

For the Galapagos organization in the Netherland , we are looking for a QA Operations Specialist as part of the Cell therapy department to join us for a 6-month project in setting up, promoting and maintaining the QA model.

Scope of the Role:

As the QA Operations Specialist, you will be responsible for providing comprehensive quality oversight for the central site. Your key responsibilities include the review and approval of records, management of deviations, and oversight of Corrective and Preventive Actions (CAPAs). Additionally, you will play a pivotal role in enhancing compliance levels across Galapagos, contributing to the overall quality culture of the organization.

Key Responsibilities:

Central site Performance Quality Oversight:

Oversee deviations, change control (CC), and CAPAs related to Cell Therapy activities.

You will engage closely with various internal stakeholders, including Site Management for Cell Therapy, Quality Control (QC) for Cell Therapy (scientists, managers), and Systems and Technology teams (engineers, leads).

Who are you?

• Bachelor's degree in a relevant field.
• Ability to work independently in a fast-paced environment, adjusting priorities as needed.
• Strong results-driven mindset with an unwavering commitment to quality and compliance.
• Proven ability to collaborate cross-functionally with internal and external stakeholders.
• Minimum of 2 years of experience in a GMP environment, with extensive knowledge of cGMP, QA processes, and Quality Management.
• Experience in commercial GMP manufacturing; experience in ATMP manufacturing is a plus.
• Demonstrated excellent interpersonal and communication skills.
• Fluent in written and spoken English, with strong technical writing skills.
• Location: Leiden, Netherlands.
• Demonstrated ability to independently design and perform activities, analyze data, and drive continuous improvement initiatives.
• Strong problem-solving skills and creativity in implementing new methods and solutions

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.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.