View Our Website View All Jobs

Sr. Quality Training Specialist

The Training Sr. Specialist is responsible for driving the design, development and delivery of training and education across BioMarin Development Sciences in areas of GxP, compliance, and Controlled Documents. The Sr. Specialist is expected to act as a training subject matter expert for the Development Sciences organization, offering guidance to customers and project teams on training-related solutions and approaches as well as input on continuous improvement and design standards related to training materials.


Course Development

  • Oversee, design, develop and implement learning programs, training courses and materials to educate/increase knowledgebase of Development Sciences employees in relation to clinical trial-related and GxP-regulated activities
  • Work with stakeholders to develop overall training strategies, programs, and curricula for specific topics or functions
  • Assess and identify training needs in collaboration with subject matter experts, cross functional leads, and key business stakeholders
  • Develop or updated training materials based on functional area needs assessments or training requirements based on document requirements (e.g., SOP)
    • Design curricula that fit the key goals of the learning program, including timeframe, expected outcomes, level of interaction and engagement, and specific audience needs
    • Work with stakeholders to finalize the training materials
  • Assist with the development of a variety of knowledge assessments, including quizzes, that suit the project or program needs
  • May collaborate and assist with managment 3rd party training contractors/vendors for complex projects


Training Execution

  • Develop and deliver training using multiple methodologies (e.g. instructor-led, e-learning, webinars)
  • Coordinate or oversee tasks as assigned, including, but not limited to, monitoring and submitting attendance to verify credit is given and any related communication.
  • Conduct and review course evaluations to verify that efficient, effective, value added training to learners is provided to DevSci personnel
  • Oversee training records management, including tracking attendance, recording learner histories, and developing training compliance metrics

Training Processes and Tools

  • Assist department to establish design standards to verify consistency in the development of training materials, websites, and tools (e.g., training intake request processing and prioritization, scope development)
  • Participate in process improvement efforts that require training implementation components  
  • Collect and share relevant industry news and practices regarding training strategies and tools
Must have good working knowledge of:
  • Regulatory environment (guidance, guidelines, trends, changes, etc.)
  • Good Clinical/laboratory/pharmacovigilance Practices (GxPs)
  • Clinical Trials and Development (e.g. phases of trials, data management principles)
  • Quality management principles and quality management system
  • BA/BS in life sciences or technical area; experience in lieu of education may be considered
  • 4+ years of relevant pharmaceutical industry experience


Read More

Apply for this position

Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 2MB) or Paste resume

Paste your resume here or Attach resume file