Otsuka Pharmaceutical Companies (U.S.) · 5 hours ago
Director, GxP Training (Princeton, Hybrid)
United States
Full-time
Hybrid
Director/Executive
$165K/yr - $246K/yr
10+ years expOtsuka Pharmaceutical Companies (U.S.) is seeking a Director, GxP Training Lead, who will be a senior leader within the Learning Center of Excellence under Global Quality. This role is responsible for developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the organization.
Health CareMedical
Responsibilities
Define and lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards
Establish governance frameworks for training compliance, including policies, SOPs, and audit readiness
Serve as the primary training authority during regulatory inspections and internal audits
Design and oversee GxP training programs for all regulated functions (e.g., R&D, Manufacturing, Clinical, Quality)
Implement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches
Ensure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH)
Monitor training compliance metrics and proactively address gaps to mitigate regulatory risk
Maintain audit-ready documentation and ensure adherence to GxP standards across global operations
Partner with functional leaders, Quality Systems, and HR to align training initiatives with business priorities
Act as a trusted advisor to senior leadership on training compliance trends, risks, and mitigation strategies
Define KPIs and leverage data analytics to measure training effectiveness and drive enhancements
Stay current with regulatory changes, industry best practices, and emerging technologies to evolve training programs
Qualification
Required
Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred
10+ years in pharmaceutical or life sciences industry with significant experience in GxP compliance and training leadership
Proven track record in designing and implementing global training programs and managing cross-functional teams
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
Excellent communication, collaboration, and stakeholder engagement skills
Preferred
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
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
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
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