Director, GxP Training

 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.

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.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

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Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.