Otsuka America Pharmaceutical Inc.
Director, GxP Training (Princeton, Hybrid)
Otsuka America Pharmaceutical Inc., Annapolis, Maryland, United States, 21403
The 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.
Key Responsibilities Strategic Leadership & Governance
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.
Program Development & Delivery
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).
Compliance & Risk Management
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.
Stakeholder Engagement & Collaboration
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.
Continuous Improvement & Analytics
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.
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 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 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.
Competencies Accountability for Results -
Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving -
Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity -
Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -
Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration -
Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development -
Play an active role in professional development as a business imperative.
Minimum $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 candidate’s 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.
Application Deadline This will be posted for a minimum of 5 business days.
Company 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).
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Key Responsibilities Strategic Leadership & Governance
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.
Program Development & Delivery
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).
Compliance & Risk Management
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.
Stakeholder Engagement & Collaboration
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.
Continuous Improvement & Analytics
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.
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 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 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.
Competencies Accountability for Results -
Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving -
Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity -
Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -
Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration -
Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development -
Play an active role in professional development as a business imperative.
Minimum $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 candidate’s 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.
Application Deadline This will be posted for a minimum of 5 business days.
Company 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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com).
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