Senior Director, Training -Global Quality

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.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.