QA Decentralized Manufacturing Unit (DMU) Manager, 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, 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 Decentralized Manufacturing Unit (DMU) Manage r located on the Northeast coast of the US to join us in setting up, promoting and maintaining the QA model for our dynamic business environment. Scope of the role As QA Operations DMU manager, you join our Quality Assurance team located in the United States. We are a fast-growing team, building a QA model for our expanding organization, working closely together with the DMU manufacturing partners. At Galapagos, we strongly believe in the power of collaboration to achieve ambitious goals. This is reflected in how we divide tasks and support each other. Our workflow is dynamic, fast and varied. Your role DMU manufacturing site qualification and onboarding DMU manufacturing quality monitoring DMU compliance oversight to enhance consistency Quality oversight of DMUs by: Representing GLPG performing "QA on the Floor" functions when required at the DMU Ensuring GLPG quality management system is followed at DMU Ensuring GLPG provides Quality support to DMU during clinical manufacturing Maintaining product quality oversight, creating consistency using Galapagos Central Reference Site capabilities and data Conducting real time batch records review Ensuring DMUs complete Deviations, CAPAs and Change Control Records on time Ensuring DMU personnel assigned to work on GLPG manufacturing and/or testing are adequately trained. Reviewing Environmental Monitoring Data Who are you? You have a Life Science or Engineering Bachelor's degree At least 3 years of experience in QA Operations role within a GMP environment with thorough working knowledge of cGMP QA processes Experience in a ATMP manufacturing setting is preferred Experience in a commercial GMP manufacturing setting is preferred You are proficient in project management You are able to travel for on-site visits to DMU sites for F2F interaction with stakeholders and QA on the Floor tasks You enjoy working in a fast-paced small company 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 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...! 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 $106,875 to $178,125. 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.

Created: 2024-11-05