Manager/Sr. Manager, Training, Quality Systems

Careers Manager/Sr. Manager, Training, Quality Systems About the Company: Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com. Function: Quality Level: Manager/Sr. Manager Location: San Carlos, CA. This position is based onsite. Reporting Manager: Sr Director, Quality About the Opportunity: The Manager/Sr. Manager, Training, Quality Systems, will manage the GxP Training Program, act as the main Training System Administrator for the eLMS and lead the execution of all GXP Training activities, including but not limited to creation and processing of training content through the Electronic Learning Management System (eLMS), conducting and managing GxP on-boarding, creating training content as required, regular live and digital employee training via the eLMS, inspection support, creation of and reporting training metrics, continued development of training matrices across GxP functions, and general Document Control support if required. Role and Responsibilities: Manage the GxP training program (guide, evaluate and implement the design and architecture of trainings within eLMS) Creation and revision of role-based training curricula to align with functional responsibilities Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Dren Bio's eLMS Support the creation and revision of Training related SOPs, work instructions, training materials in collaboration with Subject Matter Experts (SMEs) Identify, review and implement digital learning resources, including but not limited to web-based training, videos/recorded content and SCORM files. Advise subject matter experts (SMEs) on conceptualizing and sharing content. Provide training and support for employees on the use of the LMS Responsible for the development of training material using instructional design principles that best suit various training objectives Facilitate GxP training for employees, as needed Oversight of training compliance across all departments, publish periodic training reports, and escalate compliance issues to management Collaborate cross-functionally to support LMS upgrades and change management Support the timely closure of relevant Quality System records Identify and participate in initiatives to improve the training program, LMS and training content Support development of Quality Management Review content to measure the effectiveness of the training program Support audits and regulatory authority...