Manager Training – Quality Assurance

Responsibilities

• Oversee the overall Learning and Development/GxP training program to provide a robust, compliant, streamlined training program that supports GxP operations and can withstand the rigor of regulatory inspections.
• Manage the day-to-day activities in the electronic training management system.
• Serve as the Subject Matter Expert in the development, use, and lifecycle maintenance for the electronic training management system.
• Maintain GxP training records and files.
• Partner with functional departments to create and maintain the training matrix for all roles.
• Develop, deliver, and monitor GxP and general Quality Systems classroom training when needed (e.g. onboarding).
• Participate in Inspection readiness activities to ensure the training program is continuously inspection ready.
• Support audit and inspection activities by being the training subject matter expert. Act as subject matter expert for audit-related questions within subject matter area and beyond, including front room and back room support and management.
• Participate in internal audits as needed.
• Provide training metrics to monitor the health and effectiveness of the training program.
• Participate in Quality Management Meetings representing training program performance.
• Develop effective cross-functional relationships with functional areas and Kyverna Leadership to meet departmental and organizational goals.
• Serve as a liaison between functional departments and Quality.
• Ensure regulatory GxP requirements are implemented and maintain compliance.
• Familiarity with various training methodologies, including e-learning, classroom training, on-the-job training, and blended learning approaches.
• Other duties as assigned.

Requirements

• Bachelor’s degree in science or engineering discipline with 5 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry OR
• Master’s degree with 3 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry.
• Experience working in a regulated environment (cGMP/GCP/GTP) in a training role essential.
• Experience working with electronic training/learning management systems required.
• Experience creating/developing/administering SCORM or other electronic training content preferred.
• Strong knowledge of applicable regulations and standards related to Cell Therapies, Cell Collection, and Donor Requirements.
• Previous experience in designing, delivering, and evaluating training programs.
• Proficiency in designing and developing training programs, curriculums, courses, and materials that effectively convey complex scientific and technical information.
• Independently motivated, detail oriented and good problem-solving ability.
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
• Excellent verbal, written and presentation skills and effectively communicate with all levels of management.
• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
• Self-starter, works effectively in teams.