Manager​/Sr. Manager, Training, Quality Systems

Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment ofcancer, 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 celltype 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 novelphagocytic 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 fromthe platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to otherimmunomodulatory therapies. For more information, please visit our website

Quality

Manager/Sr. Manager

San Carlos, CA. This position is based onsite.

Sr Director, Quality

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 GXPTraining 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.

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 limitedto 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 inspections by providing training reports/documentation or other assigned tasks

Provide oversight and timely response of training related inquiries

Oversight of employees' resumes/CVs, and job descriptions to ensure compliance

Ensure timely generation and review of content for periodic GxP refresher trainings

Other duties as assigned

Min 5 years of experience in a GxP environment preferably in Document Control or Quality Systems role with a min of 2 years implementing, managing or working with

GxP training

Bachelor's Degree in related field preferred

Experience in the administration of electronic learning management systems

Experience in training program administration in the life sciences industry or other highly regulated industry

Experience in electronic document management systems preferred

Experience with the transition from a development to commercial organization a plus

Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance

Ability to create accurate and engaging training materials a keen eye for detail and compliance.

Superior organization skills with ability…