Senior Director, Training -Global Quality

Training COE Leadership

The Training Center of Excellence (COE) will lead the creation and execution of a 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.

Competencies :

Compensation :

Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity : The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits :

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer :

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .

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