Senior Specialist, Regulatory Programs (Part-Time)

We are seeking an experienced and dynamic Quality Regulatory Program Manager to lead our quality assurance regulatory initiatives. As the Program Manager, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards in manufacturing processes, and driving continuous improvement initiatives to enhance product quality and patient safety. This key role will develop and implement regulatory strategies leading to successful registration and life-cycle management of complex products serving patients and clients. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities.  About GeneFab GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies. We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.