Quality Management Lead R&D US

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 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 Quality Management Lead R&D to joinour R&D Quality (QA) team in the US , ensuring GxP compliance across our Discovery, Preclinical and Clinical activities. Your role Serve as the quality point-of-contact for our US R&D teams, central quality teams, and governance bodies. Build and maintain cross-functional relationships to promote GxP compliance awareness throughout the R&D organization. Provide continuous quality compliance support by acting as an internal advisor on processes and regulations and ensuring correct implementation. Ensure quality oversight and operational support for processes as e.g. CAPAs, audits, inspections, deviation management, risk management, change control and quality complaint handling. Identify, manage and mitigate quality compliance risks in collaboration with the operational and central QM teams. Collaborate with the QMS team to tailor and standardize the QMS to the specific business needs. Participate in and collaborate to continuous improvement initiatives. Support in training initiatives on processes, new regulations and systems to enable quality compliance. Assist in audit and inspection activities, including CAPA formulation, vendor assessments, and regulatory inspections. In this role, you will play a crucial role in driving a culture of quality and ensuring that compliance is embedded throughout the R&D process. Who are you? More than 10 years' experience in the pharmaceutical or biotechnology industry with in-depth pharmaceutical QMS knowledge and a minimum of 5 years in a QM environment with proven experience in discovery, as well as non-clinical and clinical development. Experience with ATMPs is required. Strong knowledge of GSP, GCP, GMP and other GxP guidelines, data integrity principles and regulatory requirements. A relationship builder with the ability to communicate complex issues clearly and effectively to diverse teams and across all organizational levels. Excellent problem solver, analytical thinker and decision-maker with a strong understanding of root cause analysis tools and methodologies. Able to navigate challenges and drive 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. 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. 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.

Created: 2024-11-04