Otsuka Pharmaceutical
Associate Director, GxP Training (Princeton, Hybrid)
Otsuka Pharmaceutical, Princeton, New Jersey, United States
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.
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.
~ Compliance & Risk Management
Ensure all training programs meet global regulatory standards (FDA, EMA, ICH, etc.) 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. 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. 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. ~ 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.
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.
Ensure all training programs meet global regulatory standards (FDA, EMA, ICH, etc.) 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. 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. 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. ~ 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.
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.