QA QC, Manager

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, 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 looking for a Manager, QA for QC

Scope of the job

Ensuring highest standards of quality,compliance, and regulatory adherence in the development of the Quality Controlactivities both on site as at the DMU manufacturing units, contributing to thesuccessful delivery of safe and effective therapies to patients.

Working in close collaboration with QCmanagement, internal stakeholders, external laboratories, and the DMU unitswith the focus on the Quality Control operation activities regarding Quality Control Operation QA Oversight, Deviation and CAPA Related to QC & Support to Development Activities.

Your role

• Ensuring quality oversight of QC activities as per internal procedures, policies & applicable regulations.
• Developing, implementing, and maintaining an effective QMS for QC in compliance with relevant regulations and standards.
• Implement risk management strategies to identify, assess, and mitigate quality risks in ATMP QC processes and Point of Care manufacturing units are compliant to applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organization) and Galapagos Polices.
• Proactively identifying, co-developing, and co-implementing technically robust systems & process improvements in response to business requirements, technical changes, and regulatory requirement.
• Developing and implementing strategies that will assure the establishment and maintenance of a state of compliance and a state of control for quality control activities.
• Continuously improving process & systems owned by QC and related services supporting
• Provide oversight for QMS QC records (e.g., methods validation, Change control, Deviations, CAPAs), ensuring accuracy, completeness, and traceability.
• Stay informed of relevant regulatory requirements and industry standards.
• Supp regulatory inspections and audits for QC activities, ensuring timely and appropriate responses to findings.
• Drive continuous improvement initiatives to enhance efficiency, reduce errors, and optimize processes within the quality system.
• Analyze quality data to identify trends and areas for improvement.
• Provide training on quality control policies, procedures, and regulations to QA and QC personnel.
• Foster a culture of quality and compliance throughout the organization.

Who are you ?

• With at least 5 years of experience in a role within a GMP environment with thorough working knowledge of cGMP QA or QC processes: QA management and Good Manufacturing Practices.
• Experience in a commercial GMP manufacturing setting is preferred
• Experience in an ATMP manufacturing setting is preferred
• You have proven excellent interactive skills
• You are able to be on-site 80% of the time.
• You enjoy working in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
• Result-driven and can-do mindset, without compromising quality and compliance
• You are an independent thinker and resourceful
• You have good interpersonal skills and written and spoken fluency in English
• Hybrid location with travel to Leiden, NL on regular basis.