Talent.com
Director, GxP Training
Director, GxP TrainingOtsuka Pharmaceutical • Princeton, NJ, US
Director, GxP Training

Director, GxP Training

Otsuka Pharmaceutical • Princeton, NJ, US
6 hours ago
Job type
  • Full-time
Job description

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.
  • Create a job alert for this search

    Director Training • Princeton, NJ, US

    Related jobs
    Pharmaceutical Sales Training Manager

    Pharmaceutical Sales Training Manager

    Syneos Health / inVentiv Health Commercial LLC • Bridgewater, NJ, United States
    Part-time +1
    You're driven, resourceful, and above all else - remarkably smart.The Training Manager (TM) is primarily responsible for the successful delivery, execution, and management of all training-related n...Show more
    Last updated: 17 days ago • Promoted
    Travel Home Health Geriatric Physical Therapist - $2,654 per week

    Travel Home Health Geriatric Physical Therapist - $2,654 per week

    American Traveler • Bordentown, NJ, United States
    Full-time
    American Traveler is seeking a travel Home Health Physical Therapist for a travel job in Bordentown, New Jersey.Job Description & Requirements. American Traveler is seeking an experienced Home Healt...Show more
    Last updated: 18 days ago • Promoted
    Construction Program Systems Director

    Construction Program Systems Director

    Ferreira Construction Co., Inc. • Branchburg, NJ, United States
    Full-time
    Construction Program Systems Director.The Construction Program Systems Director will lead the company’s software strategy, focusing on the optimization and integration of CMiC ERP systems to enhanc...Show more
    Last updated: 1 day ago • Promoted
    Travel Physical Therapist - $2,276 per week

    Travel Physical Therapist - $2,276 per week

    CompHealth Inc. • Levittown, PA, United States
    Permanent
    Physical Therapist for a travel job in Levittown, Pennsylvania.Job Description & Requirements.Interested in this assignment? Or maybe you still have not found what you are looking for? Contact one ...Show more
    Last updated: 9 days ago • Promoted
    Director, WW Commercialization Analytics- Oncology

    Director, WW Commercialization Analytics- Oncology

    Bristol Myers Squibb • Princeton, NJ, US
    Full-time
    Strategic Business Partner, Oncology Global Commercial Strategy.Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual.Here, uniquely in...Show more
    Last updated: 4 hours ago • Promoted • New!
    Director, GxP Training

    Director, GxP Training

    Otsuka Pharmaceutical • Princeton, New Jersey, US
    Internship
    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 strat...Show more
    Last updated: 11 hours ago • Promoted • New!
    Executive Director of Regulatory Ad / Promo

    Executive Director of Regulatory Ad / Promo

    EPM Scientific • Bridgewater, NJ, US
    Full-time
    Executive Director of Regulatory Affairs Ad / Promo.A global health care company, dedicated to improving people's lives through innovative solutions specialized in pharmaceuticals, medical devices, a...Show more
    Last updated: 30+ days ago • Promoted
    SBHS Dramatics : WINTER Play

    SBHS Dramatics : WINTER Play

    South Brunswick Township School District • Monmouth Junction, NJ, United States
    Full-time
    Set Design Director, per production.Must have a valid NJ Teaching Certificate or hold a Substitute Teacher Credential.All applicants must complete and submit an on-line application.The application ...Show more
    Last updated: 30+ days ago • Promoted
    Behavioral Medical Director licensed and residency in New Jersey - Remote

    Behavioral Medical Director licensed and residency in New Jersey - Remote

    UnitedHealth Group • Basking Ridge, NJ, United States
    Remote
    Full-time
    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives.The work you do with our team will directly improve health outcomes by connect...Show more
    Last updated: 30+ days ago • Promoted
    Travel - MRI Tech

    Travel - MRI Tech

    Titan Medical (Nebraska) • Bordentown, NJ, United States
    Full-time
    WHEN YOU WORK FOR US, WE WORK FOR YOU.With Titan Medical, you gain access to thousands of travel nursing and allied health jobs across the country. You also get unmatched service.From the moment you...Show more
    Last updated: 1 day ago • Promoted
    Program Director

    Program Director

    Beacon Specialized Living • Trenton, NJ, US
    Full-time
    Position Summary : • The Program Director oversees assigned Beacon locations to ensure that company goals, budgets, and clinical effectiveness targets are met. They support Care Team Managers by ensur...Show more
    Last updated: 8 hours ago • Promoted • New!
    Side Hustle Project Lead

    Side Hustle Project Lead

    Finance Buzz • Joint Base Mdl, New Jersey, US
    Full-time +1
    We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...Show more
    Last updated: 30+ days ago • Promoted
    Senior Manager - Commercial Pipeline & Manager Products

    Senior Manager - Commercial Pipeline & Manager Products

    Cipla USA • Warren, NJ, United States
    Full-time
    Senior Manager- Commercial Pipeline & Manager Products, Institutional.Head Business Operations - Institutional Business.Support Institutional Strategy for Growth. Explore and evaluate short- and lon...Show more
    Last updated: 30+ days ago • Promoted
    Travel Outpatient Physical Therapist

    Travel Outpatient Physical Therapist

    Jackson Therapy Partners • Bordentown, NJ, US
    Full-time +1
    Jackson Therapy Partners is seeking a travel Outpatient Physical Therapist for a travel job in Bordentown, New Jersey.Job Description & Requirements. Looking for a change of scenery and a chance...Show more
    Last updated: 30+ days ago • Promoted
    Director, Data Insights & Innovation

    Director, Data Insights & Innovation

    QuidelOrtho • Raritan, NJ, United States
    Full-time
    QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecula...Show more
    Last updated: 25 days ago • Promoted
    Travel Physical Therapy Assistant - $1,595 per week

    Travel Physical Therapy Assistant - $1,595 per week

    Care Career • Levittown, PA, United States
    Full-time
    Care Career is seeking a travel Physical Therapy Assistant for a travel job in Levittown, Pennsylvania.Job Description & Requirements. Under the direction and supervision of physical therapists, phy...Show more
    Last updated: 16 days ago • Promoted
    Executive Director, Compliance

    Executive Director, Compliance

    Larson Maddox • Trenton, NJ, US
    Full-time
    My client is a Publicly-Traded Commercial Stage Biopharma Company that is seeking an experienced Compliance professional to drive the evolution and execution of the Compliance Program.The Company i...Show more
    Last updated: 30+ days ago • Promoted
    Athletic Director - Raritan Valley Community College

    Athletic Director - Raritan Valley Community College

    Raritan Valley Community College • Branchburg, NJ, United States
    Full-time
    Administrative and Professional.The Athletic Director (AD) has a key role in supporting the overall objectives of the college, particularly in promoting student-athlete academic excellence.As a mem...Show more
    Last updated: 30+ days ago • Promoted