Director, Training Management Operations (Princeton, Hybrid)

Otsuka Pharmaceutical • Princeton, NJ • 1d ago

Director, Training Management Operations Lead

The Director, Training Management Operations Lead, is a senior leader within the Learning Center of Excellence (CoE) under Global Quality. This role is responsible for overseeing the end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality objectives. The position drives governance, technology enablement, and process optimization for training systems and programs across GxP and non-GxP functions.

Key Responsibilities:

Strategic Leadership & Governance

Define and execute the global training operations strategy within the Learning CoE to support quality and compliance objectives.
Establish governance frameworks for training management, including policies, SOPs, and audit readiness.
Serve as the primary point of contact for training operations during regulatory inspections and internal audits.

Training Systems & Technology Enablement

Oversee the administration and optimization of Learning Management Systems (LMS) and related platforms.
Partner with IT and business stakeholders to implement innovative digital solutions that enhance learner experience and compliance tracking.
Ensure data integrity and system validation in accordance with GxP requirements.

Operational Excellence

Lead global training operations teams responsible for scheduling, tracking, and reporting compliance training.
Develop and monitor KPIs to measure operational performance and training effectiveness.
Drive continuous improvement initiatives to streamline processes and reduce compliance risk.

Stakeholder Engagement & Collaboration

Collaborate with Quality, HR, and functional leaders to align training operations with organizational priorities.
Provide strategic guidance to senior leadership on training compliance trends, risks, and mitigation strategies.

Budget & Resource Management

Manage operational budgets and resources to ensure efficient delivery of training programs.
Oversee vendor relationships for training services and technology solutions.

Qualifications:

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 training operations and GxP compliance.
Proven track record in managing global training systems and leading cross-functional teams.
Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.).
Expertise in LMS administration, data analyics, and process optimization.
Excellent communication, stakeholder management, and project leadership skills.

Preferred Attributes:

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.

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