Learning Management System (LMS) Manager, GxP Training

Novato, CA
Ultragenyx – Quality
Full-time

Why Join Us? 
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies. 
 
Come join our team during this exciting time of growth and opportunities!
 
We are located in Novato, CA, 25 miles north of San Francisco with additional office space in Brisbane, California and Basel Switzerland.
 
Position Summary
 
Ultragenyx is undergoing an organizational transformation that requires efficient and effective on-boarding of new hires into a highly regulated global workplace. Reporting to the Head of GxP Training, Ultragenyx is seeking a highly motivated and experienced learning management system (LMS) manager with  tactical and strategic LMS experience that includes mapping training and learning processes to system requirements and functions.  This individual is responsible for maintaining and operating learning management system in a highly regulated environment. A key success factor is supporting learning processes across the organization in a compliant manner. In addition, this individual will have the opportunity to help guide the strategic direction of the LMS along with executing processes, tools and validation activities across the company.
 
Position will have some additional responsibility for authoring, facilitation, and instructional design and development of training materials.
 
The position is based in Novato with travel to Brisbane, CA as needed.  
 

Responsibilites include but limited to:

    • Expertise in learning management system functionality, particularly Compliance Wire with attention to user management; assignments/curricula design, development, and deployment; report design and generation
    • Manage LMS business requirements and update appropriate documentation when needed
    • Contribute to the standard operating procedures for operating and maintaining the LMS to ensure compliance adherence
    • Provide diagnostic and continuous improvement insights to ensure learning processes are supported, efficient, and effective
    • Expertise in SCORM and AICC conformance standards as it relates to eLearning deployment
    • Responsible for accurate and timely data entry for users, assignments/curriculum provisioning, and reports in the LMS
    • Provisioning of the LMS and Its infrastructure that ensure compliance with applicable global GxP requirements, including validation, testing, risk assessment, and configuration activities in collaboration with the computer system validation (CSV) subject matter experts
    • Support inspection readiness activities and associated internal audits and Health Authority Inspections by providing the appropriate LMS reports
    • Active collaboration with functional Subject Matter Experts and business owners to support the learning activities using the LMS
    • Provide authoring of eLearning courses, Articulate experience a plus
    • Work with external parties (e.g. consultants, Suppliers, contractors, etc.) to execute learning programs in the LMS
    • Ensure the accurate and timely coordination of training logistics
    • Provide classroom instruction

Requirements:

    • Bachelor's Degree required, preferably in Training, Biological Sciences, or Information Technology
    • Operating and maintaining a learning management system, Certification in Basic and/or Advanced ComplianceWireâ„¢ Administration a plus
    • Design, develop, and deploy instructional materials using ADDIE or other appropriate instructional design models to a wide range of learners for both technical and non-technical material
    • Design, develop, and deploy eLearning, Articulate experience a plus
    • Provide classroom management, including facilitation and coordination
    • Able to define and implement training effectiveness measurements
    • Proficient in MS applications such as Power Point, Word, and Excel
    • Minimum of 2 years-experience in Training and/or Quality with experience in the pharmaceutical, biotech or other related life-sciences industry as a  plus
    • Minimum of 2 years-experience in managing a LMS with that being in the pharmaceutical, biotech or other related life-sciences industry as a plus
    • Proficient in cGMP's and pharmaceutical industry procedures and regulations a plus
    • Strong influencing skills and creative problem solving capabilities
    • Exceptional teamwork and collaboration skills with internal and external subject matter experts
    • Be able to provide real-time resolutions and approaches balanced with long-term objectives
    • Acts with a sense of urgency and be self-motivated with the ability to demonstrate initiative

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

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