Senior Manager, GxP Training
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
The Denali Sr. Manager of GxP Training, reporting to the Head of Development Quality, is accountable for defining and delivering the strategy and execution for Denali’s employee GxP Training program. This includes strategic management of the organization’s GxP Learning Management System (LMS), and building the GxP training team. This role will work closely with training partners and GxP functions to develop and deliver best-in-class training strategies while ensuring a high level of GxP training compliance across the organization.
Responsible for collaborating and consulting with internal stakeholders to create, revise, and maintain curricula, training items and user groups in the Learning Management System (LMS)
- Oversee the development and delivery of training utilizing multiple platforms (i.e. face-to-face, e-learning, webinars, etc.).
- Promote a quality culture at Denali to drive enthusiasm for learning and training compliance
- Prioritize training needs using a risk-based approach with a philosophy of delivering the right training at the right time
- Provide metrics as directed to Quality groups to measure the effectiveness of GxP training programs within Denali
- Maintain and implement GxP training policies and procedures. Identify opportunities for improvements.
- Partner with the other Learning leaders in the organization to ensure that the GxP training strategy and delivery is aligned within Denali’s overall L&D standards and philosophy. Actively collaborate and present solutions to contribute to a seamless learning experience for Denali employees as the GxP Training SME.
- Coach Subject Matter Experts on GxP course and curriculum development
- Facilitate and oversee a range of learning opportunities to ensure employees across the organization have the skills needed to be effective, qualified and compliant in their GxP roles/functions
- Proven track record managing a Gxp Training program within highly regulated healthcare, biotech, or pharmaceutical environments
- Always operates with the highest level of integrity and transparency
- Enthusiasm and passion for the role GxP training plays in bringing safe, effective treatments to patients
- Advanced relevant degree preferred, or 5+ years of related experience
- Excellent understanding of LMS best practices to meet learners’ needs and fulfill compliance objectives
- Ability to negotiate, influence, and facilitate
- Current knowledge of effective learning and development methods, and passion for continuous improvement
- Familiarity with e-learning platforms and practices
- Ability to support audits and inspections as the GxP Training SME as directed
- Excellent communicator and ability to work productively with a wide variety of stakeholders
- Able to work in a quickly changing and demanding environment
- Team-oriented with ability to listen, adapt and respond to changing needs
- Must be comfortable with both strategy and execution
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary Range: $130,300 to $170,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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