Global Quality Operations Manufacturing Senior Specialist

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.

• We are looking for a Global Quality Operations Manufacturing Senior Specialist to join our team for a period of 6 months as Consultant.

Project Scope

• Review ATMP manufacturing batch records

• Deviations, CAPA and change control management

• Assure quality and compliance of GMP manufacturing

• Identify areas for continuous improvement projects

Your mission

• DMU monitoring - Clinical batch review for connected DMUs

• Manage quality management  attributes for DMU and Central Site activities: Deviations, CAPAs and Change Controls

• QA representative for any Kitting or SAP related items

• QA Support in Kitting batch execution form review and SAP release of Kits

• QA representative for review and approval of Kit configuration updates

• QA representative for review of Kit configuration notification

• SAP Kit BOM and Treatment BOM activation/ inactivation in SAP – including completion of SAP Audit trail

• Manage quality management attributes for Kitting/ SAP and Supply Chain related activities: Deviations, CAPAs, Change Controls and Complaints.

• QA representative for block and/ or unblock activities (e.g. related to occurred deviations, which require the correct follow up)

• Review and approval of Kitting, Supply Chain and SAP related procedures

• QA representative for DMU Return shipments

• Logbook initiation for Finch site

Who are you?

• Have a relevant degree in Biology / Biotech Sciences / Chemistry, Masters or Bachelor

• 3- 5 years of experience in a role within a GMP environment and have working knowledge of cGMP QA processes

• GMP experience is required, experience in an ATMP and a commercial GMP manufacturing setting is preferred

What's in it for you? 

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

To streamline our hiring process, we kindly request that only individual freelancers and our preferred vendors submit CVs directly to us. Applications sent by non-preferred agencies, recruitment firms, or other third parties on behalf of freelancers will not be considered. This approach helps us maintain an efficient and direct connection with top talent, ensuring a smooth experience for all involved.