Associate Director, GxP Training (Princeton, Hybrid)

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

6d • $146,955 - $219,650 • Hybrid

About The Position

The Associate Director, GxP Training, is a critical member of the Learning Center of Excellence within Global Quality. This role is responsible for developing and maintaining robust training programs that ensure compliance with Good Practice (GxP) regulations across the organization. The position will lead the design, implementation, and governance of global learning strategies that support regulatory readiness, operational excellence, and a strong quality culture.

Requirements

• Bachelor’s degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred.
• 8+ years of experience in learning and development, preferably within the pharmaceutical, biotech, or healthcare industry with a focus on GxP compliance and training.
• Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.).
• Proven ability to design and deliver impactful learning programs using adult learning principles.
• Experience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies.
• Expertise in instructional design, adult learning principles, and digital learning technologies.
• Excellent communication, stakeholder management, and project leadership skills.

Nice To Haves

• Strategic thinker with a passion for scientific learning and development.
• Agile and adaptable in a fast-paced, matrixed environment.
• Strong project management and organizational skills.
• Committed to fostering innovation, compliance, and continuous improvement through learning.

Responsibilities

• Define and execute the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives.
• Establish governance frameworks for training compliance, including policies, procedures, and audit readiness.
• Design and oversee GxP training programs for diverse functions (e.g., R&D, Manufacturing, Quality, Clinical, and Commercial).
• Develop innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches.
• Ensure all training programs meet global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs.
• Monitor training compliance metrics and proactively address gaps to mitigate regulatory risk.
• Partner with functional leaders, Quality Systems, and HR to align training initiatives with business needs.
• Serve as a subject matter expert on GxP learning during audits and inspections.
• Define KPIs and utilize data analytics to measure training effectiveness and drive continuous improvement.
• Stay current with regulatory changes, industry trends, and emerging technologies to evolve training programs.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees