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Otsuka Pharmaceutical Companies (U.S.) · 1 day ago

Associate Director, GxP Training (Princeton, Hybrid)

United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$147K/yr - $220K/yr

8+ years exp

Otsuka Pharmaceutical Companies (U.S.) is seeking an Associate Director, GxP Training, who will play a crucial role in the Learning Center of Excellence within Global Quality. This position is responsible for developing and maintaining training programs that ensure compliance with Good Practice (GxP) regulations across the organization, while also leading the design and implementation of global learning strategies.

Health CareMedical

Comp. & Benefits

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

Qualification

GxP complianceLearning program designRegulatory knowledgeInstructional designLearning technologiesStakeholder managementData analyticsProject leadershipCommunication skills

Required

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