Global QC CMC and Compliance Lead - Leiden (Nl)

Pleased to meet you, we are Galapagos , a dynamic growing Biotech company with offices across Europe and in the 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, point-of-care 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 seeking a highly motivated QC Submissions and Compliance Lead to join our Global Quality Control team located in Leiden, The Netherlands . The Global Quality Control team is responsible for both the central site QC activities as well as defining global standards and policies, which involve testing, sample management, method lifecycle, material risk management, product release strategy and subsequent regulatory submission documents for the sections related to product specifications, excipients, analytical and microbiological testing.

In this role, you is responsible for representing Quality Control in CMC discussions and regulatory filings (i.e. IMPDs, INDs) activities for new products, variations and updates. This includes tracking and coordinating regulatory changes, associated change controls, impact assessments and revision of related documentation (i.e. source documentation). The Lead for Global QC Submissions and Compliance should have attention to detail and ability to work in a fast-paced environment. Next to that the role is overseeing compliance enhancement initiatives at the central site as well as close out of QC related Quality Records.

Your role

• Lead the CMC discussions and regulatory filings on behalf of Quality Control for new products, variations and updates including authoring and/or providing input, monitoring changes, executing change controls, impact assessment and revisions of related documentation
• Represent Quality Control by providing and communicating an internally aligned CMC strategy
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
• Monitor and coordinate the different CMC and regulatory changes or commitments related to materials, product specifications, analytical methods, generated analytical data, stability and outsourcing activities
• Lead and support change controls, impact assessments, deviations and CAPAs
• Write and revise source documents while ensuring their accuracy and alignment with the different submissions
• Ensure timely delivery of quality and training records to meet KPIs
• Support health authority questions, including inspections

Who are you?

• MSc or PhD degree in Life Sciences, Biotechnology, related discipline
• 6-10 years of work experience in the pharmaceutical or biotech industry in quality control or analytical development
• Knowledge and experience of analytical techniques such as flow cytometry, PCR and/or biological
• Advanced understanding of cGMPs, EU and US regulations, especially related to ATMPs
• Previous experience in setting an operationally compliant quality control laboratory and processes preferred
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Self-driven and can-do, innovative and pragmatic mindset, without compromising quality
• Fluent in English

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…!