QA for QC Manager, Associate Director

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 QA for QC Manager, Associate Director. Scope of the job As QA for QC Associate Director , you ensure highest standards of quality, compliance, and regulatory adherence in the establishment of the Quality Control activities at the DMUs and at the future GLPG QC laboratories in the US, contributing to the successful delivery of safe and effective therapies to patients. Working in close collaboration with QC management, internal stakeholders, external laboratories, and the DMU units with the focus on the Quality Control operation activities. Your role: The QA for QC Associate Director supports and collaborates on the Quality oversight of Analytical Testing, Release Specifications, Stability Studies, Analytical Ref. Standards, Analytical Method Transfers, and material release testing. The Associate Director of QA for QC is also giving support on Method Qualification/Validation Documents related to GMP. Key Responsibilities: QA Oversight of Quality Control Operations responsibilities: Ensure quality oversight of QC activities in accordance with internal procedures, policies, and applicable regulations at GLPG QC Labs in the US and the DMUs. Leads Quality Management System (QMS) applicable to QC in compliance with relevant regulations and standards. Overlooks clinical and commercial sample management. Conduct QA reviews of QC release testing records. Oversee the incoming goods disposition process (e.g., LVV, Cocoon cartridge) for material sourced in the US and to be used for US Kitting. Execute data integrity risk assessments and define controls and mitigations for internal and DMU testing. Responsible for Risk, Deviation and CAPA Related to QC: Implement risk management strategies to identify, assess, and mitigate quality risks in ATMP QC processes and ensure DMUs QC laboratories are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH). Provide oversight for QMS QC records (e.g., method validation, change control, deviations, CAPAs), ensuring accuracy, completeness, and traceability. Address raw material-related deviations (e.g., QC laboratory samples and reagents in fridge and freezer). Conduct deviation investigations DMUs related QC records. Proactively identify, co-develop, and co-implement technically robust systems and process improvements in response to business requirements, technical changes, and regulatory requirements. Supporting and leading improvement projects Related to QC: Continuously improve processes and systems owned by QC and related supporting services. Support 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. Who are you ? Qualifications: Bachelor's degree in a relevant field. Minimum of 8 years of experience in a GMP environment with comprehensive knowledge of cGMP QA or QC processes. Communicate fluently in English, both written and spoken. Proven experience in a commercial GMP manufacturing setting. Preferred experience in an ATMP manufacturing setting. Demonstrated ability to work independently with minimal direction and adjust workload based on changing priorities. Strong interpersonal skills and the ability to present work effectively in various settings. Proven ability to collaborate proactively and manage projects efficiently. Fast-paced environment requiring flexibility and a can-do mindset without compromising quality and compliance. Foster a culture of quality and compliance throughout the organization. Work Environment: Hybrid working model with regular travel to multiple DMUs in the US, Pittsburgh PA, Princeton NJ and Leiden, NL. Ability travel 50% of the time. 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. Base compensation for this position ranges from $129,375 to $215,625. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in both Galapagos' performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life. We are Galapagos : together we can make it happen...!

Created: 2024-11-05