Director, GxP Training

divh2Director, GxP Training Lead/h2pThe Director, GxP Training Lead, is 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. The position provides strategic oversight for training governance, program design, and operational excellence, enabling the organization to meet inspection readiness and continuous improvement goals./ppstrongKey Responsibilities:/strong/ppstrongStrategic Leadership Governance/strong/pulliDefine and lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards./liliEstablish governance frameworks for training compliance, including policies, SOPs, and audit readiness./liliServe as the primary training authority during regulatory inspections and internal audits./li/ulpstrongProgram Development Delivery/strong/pulliDesign and oversee GxP training programs for all regulated functions (e.g., RD, Manufacturing, Clinical, Quality)./liliImplement innovative learning solutions leveraging adult learning principles, digital platforms, and blended learning approaches./liliEnsure training content is accurate, current, and aligned with global regulatory requirements (FDA, EMA, ICH)./li/ulpstrongCompliance Risk Management/strong/pulliMonitor training compliance metrics and proactively address gaps to mitigate regulatory risk./liliMaintain audit-ready documentation and ensure adherence to GxP standards across global operations./li/ulpstrongStakeholder Engagement Collaboration/strong/pulliPartner with functional leaders, Quality Systems, and HR to align training initiatives with business priorities./liliAct as a trusted advisor to senior leadership on training compliance trends, risks, and mitigation strategies./li/ulpstrongContinuous Improvement Analytics/strong/pulliDefine KPIs and leverage data analytics to measure training effectiveness and drive enhancements./liliStay current with regulatory changes, industry best practices, and emerging technologies to evolve training programs./li/ulpstrongQualifications:/strong/pulliBachelors degree required; advanced degree in Life Sciences, Education, Organizational Development, or related field preferred./lili10+ years in pharmaceutical or life sciences industry with significant experience in GxP compliance and training leadership./liliProven track record in designing and implementing global training programs and managing cross-functional teams./liliStrong understanding of RD functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.)./liliProven ability to design and deliver impactful learning programs using adult learning principles./liliExperience with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies./liliExcellent communication, collaboration, and stakeholder engagement skills./li/ulpstrongPreferred Attributes:/strong/pulliStrategic thinker with a passion for scientific learning and development./liliAgile and adaptable in a fast-paced, matrixed environment./liliStrong project management and organizational skills./liliCommitted to fostering innovation, compliance, and continuous improvement through learning./li/ulpstrongCompetencies:/strong/pullistrongAccountability for Results:/strong Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change./lilistrongStrategic Thinking Problem Solving:/strong Make decisions considering the long-term impact to customers, patients, employees, and the business./lilistrongPatient Customer Centricity:/strong Maintain an ongoing focus on the needs of our customers and/or key stakeholders./lilistrongImpactful Communication:/strong Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka./lilistrongRespectful Collaboration:/strong Seek and value others perspectives and strive for diverse partnerships to enhance work toward common goals./lilistrongEmpowered Development:/strong Play an active role in professional development as a business imperative./li/ulpMinimum $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidates job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws./ppApplication Deadline: This will be posted for a minimum of 5 business days./ppCompany 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./p/div