Associate Director of GxP Training (Boston)

The Associate Director of GxP Training is a vital member of the Learning Center of Excellence within Global Quality. This role is focused on developing and maintaining effective training programs that ensure compliance with Good Practice (GxP) regulations throughout the organization. You will take the lead in designing, implementing, and governing global learning strategies that support regulatory readiness, operational excellence, and a robust quality culture. Key Responsibilities: Learning Strategy & Governance Define and implement the global GxP training strategy in alignment with regulatory requirements and corporate quality objectives. Establish governance frameworks for training compliance, which include policies, procedures, and audit readiness. Program Development & Delivery Design and manage GxP training programs across various functions (e.g., R&D, Manufacturing, Quality, Clinical, and Commercial). Create innovative learning solutions that leverage adult learning principles, digital platforms, and blended learning approaches. Compliance & Risk Management Ensure all training programs adhere to global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. Monitor training compliance metrics and proactively address gaps to reduce regulatory risk. Stakeholder Collaboration Collaborate with functional leaders, Quality Systems, and HR to align training initiatives with business needs. Act as a subject matter expert on GxP learning during audits and inspections. Continuous Improvement & Analytics Define KPIs and utilize data analytics to measure training effectiveness and promote continuous improvement. Stay updated with regulatory changes, industry trends, and emerging technologies to refine training programs. Qualifications: 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.). Demonstrable ability to design and deliver impactful learning programs utilizing 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. Preferred Attributes: Strategic thinker committed to fostering scientific learning and development. Agile and adaptable in a fast-paced, matrixed environment. Strong project management and organizational skills. Dedicated to innovation, compliance, and ongoing improvement through learning. Competencies: Accountability for Results

- Focus on key strategic objectives, maintain high performance standards, and actively lead change. Strategic Thinking & Problem Solving

- Make decisions with a long-term impact on customers, patients, employees, and the business in mind. Patient & Customer Centricity

- Continuously focus on the needs of our customers and key stakeholders. Impactful Communication

- Communicate logically, clearly, and respectfully to influence at all levels for optimal outcomes. Respectful Collaboration

- Value diverse perspectives and seek partnerships to work towards common goals. Empowered Development

- Actively engage in professional development as a key business imperative. Salary range: Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity. The range reflects a typical pay range or starting pay for individuals hired in the role in the United States. Actual pay may vary based on job experience, specific skills, and comparison to internal incumbent roles. Application Deadline:

This listing will remain open for a minimum of 5 business days. Company Benefits:

Comprehensive medical, dental, vision, and prescription drug coverage, life insurance, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) match, flexible time off, paid holidays, and other company benefits. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. This job description is intended to describe the general nature and level of work performed in this position and is not exhaustive of every responsibility specific to the role. Otsuka reserves the right to change responsibilities to meet organizational needs as necessary.