Senior Director, Training -Global Quality Job at Otsuka Pharmaceutical, Princeton, NJ

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  • Otsuka Pharmaceutical
  • Princeton, NJ

Job Description

The Training COE will lead the creation and execution of a Center of Excellence (CoE) for GxP & non-GXP learning and development. The role will oversee a global team dedicated to designing and delivering best-in-class training programs in GxP compliance, Ethics & Compliance, and Pharmacovigilance, ensuring alignment with regulatory requirements and business objectives. This strategic leader will be responsible for transforming the employee training experience by driving innovation, standardization, and operational efficiency across the organization.

Key Responsibilities

  • Establish and lead a Global Learning & Development Center of Excellence, setting the vision, strategy, and governance for enterprise training programs.
  • Design and implement a modern, scalable, and engaging training ecosystem that enhances employee learning experiences and supports regulatory compliance.
  • Oversee the development and global deployment of training programs in:
    • GxP (Good Manufacturing/Clinical/Laboratory Practice) compliance
    • Ethics and Compliance
    • Pharmacovigilance
  • Partner with Quality, Regulatory, R&D, Manufacturing, Supply Chain, and IT to ensure training programs are aligned with business needs and evolving regulatory expectations.
  • Drive process optimization and digital transformation in training delivery, leveraging learning technologies (e.g., LMS, LXP, AI-based learning tools).
  • Ensure global training programs meet regulatory inspection readiness and support audit preparedness.
  • Develop and monitor key performance indicators (KPIs) to measure training effectiveness, compliance, and continuous improvement.
  • Lead and develop a high-performing global L&D team, fostering a culture of innovation, accountability, and excellence.
  • Stay current with industry trends, adult learning methodologies, and regulatory changes to inform strategy and maintain a competitive edge.

Qualifications

Required

  • Bachelor’s degree in Life Sciences, Education, Organizational Development, or related field
  • Minimum 15+ years of progressive experience in Learning & Development, with at least 5 years in a senior leadership role in a regulated industry (pharmaceutical, biotech, or healthcare).
  • Deep understanding of GxP, Ethics & Compliance, and Pharmacovigilance training requirements in a global pharmaceutical environment.
  • Proven experience establishing and scaling a global L&D function or Center of Excellence.
  • Strong knowledge of learning technologies, including Learning Management Systems (LMS), content authoring tools, and digital learning platforms.
  • Demonstrated success in leading global teams, managing complex projects, and driving cultural and operational change.
  • Excellent communication, stakeholder engagement, and strategic planning skills.

Preferred

  • Experience with regulatory inspections and training documentation for agencies such as FDA, EMA, MHRA, and PMDA.
  • Certification in Instructional Design, Adult Learning, or Organizational Development.
  • Familiarity with AI-driven learning platforms and data analytics in training.

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