Director of Global Training Operations
Otsuka America Pharmaceutical Inc., Denver, Colorado, United States, 80285
Director of Global Training Operations
The Director of Global Training Operations is a pivotal leader within the Learning Center of Excellence (CoE) under Global Quality. This role focuses on managing global training operations effectively, ensuring adherence to regulatory requirements while maximizing operational efficiency and aligning with the corporate quality objectives. You will lead initiatives in governance, technology adoption, and process enhancement for training systems across both GxP and non-GxP functions.
Key Responsibilities:
Strategic Leadership & Governance
Develop and implement a global training operations strategy to meet quality and compliance goals.
Establish robust governance frameworks, including policies, SOPs, and readiness for audits.
Act as the primary contact for training operations during regulatory inspections and audits.
Training Systems & Technology Enablement Oversee the management and optimization of Learning Management Systems (LMS) and similar platforms.
Collaborate with IT and business partners to create innovative digital solutions that enhance learning and compliance monitoring.
Ensure data integrity and system validation complies with GxP requirements.
Operational Excellence Lead teams responsible for the scheduling, tracking, and reporting of compliance training on a global scale.
Develop and assess KPIs to gauge the effectiveness of training and operational performance.
Initiate continuous improvement programs to streamline processes and minimize compliance risk.
Stakeholder Engagement & Collaboration Work alongside Quality, HR, and functional leaders to align training operations within organizational directives.
Offer strategic advice to senior management on training compliance trends, risks, and strategies for mitigation.
Budget & Resource Management Oversee budgets and resources to ensure effective delivery of training initiatives.
Manage vendor relationships pertaining to training services and technology solutions.
Qualifications: Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or similar field preferred.
10+ years of experience in the pharmaceutical or life sciences industry, particularly in training operations and GxP compliance.
Demonstrated success in managing global training systems and leading cross-functional teams.
Strong understanding of R&D functions and regulatory frameworks (GxP, ICH, FDA, EMA, etc.).
Expertise in LMS management, data analysis, and process improvement.
Exceptional communication, stakeholder management, and leadership abilities.
Preferred Attributes: Strategic thinker with a strong commitment to scientific learning and development.
Adaptable and agile in a fast-paced, matrixed organization.
Excellent project management and organizational skills.
Dedicated to fostering innovation, compliance, and continuous improvement through education.
Competencies: Accountability for Results:
Maintain a focus on key strategic objectives and uphold high performance standards while actively leading change.
Strategic Thinking & Problem Solving:
Make decisions considering the long-term impact on customers, patients, employees, and business outcomes.
Patient & Customer Centricity:
Keep a constant focus on the needs of customers and stakeholders.
Impactful Communication:
Communicate clearly and respectfully while influencing all levels to achieve optimal outcomes.
Respectful Collaboration:
Value diverse perspectives and seek partnerships to work towards common goals.
Empowered Development:
Take an active role in fostering professional growth as a business priority.
This position offers a competitive salary range of $164,530.00 to $245,985.00, alongside incentive opportunities. Factors such as job experience and specific skills will influence actual compensation. Our benefit package includes comprehensive medical, dental, vision, prescription coverage, basic life, disability insurance, tuition reimbursement, and a generous 401(k) match, among others. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be considered for employment without regard to any legally protected characteristic. For individuals requiring reasonable accommodations due to a disability in the application process, please reach out directly for support. Be cautious of fraudulent job offers posing as Otsuka representative communications. Otsuka only engages through its official career channels.
Establish robust governance frameworks, including policies, SOPs, and readiness for audits.
Act as the primary contact for training operations during regulatory inspections and audits.
Training Systems & Technology Enablement Oversee the management and optimization of Learning Management Systems (LMS) and similar platforms.
Collaborate with IT and business partners to create innovative digital solutions that enhance learning and compliance monitoring.
Ensure data integrity and system validation complies with GxP requirements.
Operational Excellence Lead teams responsible for the scheduling, tracking, and reporting of compliance training on a global scale.
Develop and assess KPIs to gauge the effectiveness of training and operational performance.
Initiate continuous improvement programs to streamline processes and minimize compliance risk.
Stakeholder Engagement & Collaboration Work alongside Quality, HR, and functional leaders to align training operations within organizational directives.
Offer strategic advice to senior management on training compliance trends, risks, and strategies for mitigation.
Budget & Resource Management Oversee budgets and resources to ensure effective delivery of training initiatives.
Manage vendor relationships pertaining to training services and technology solutions.
Qualifications: Bachelor's degree required; advanced degree in Life Sciences, Education, Organizational Development, or similar field preferred.
10+ years of experience in the pharmaceutical or life sciences industry, particularly in training operations and GxP compliance.
Demonstrated success in managing global training systems and leading cross-functional teams.
Strong understanding of R&D functions and regulatory frameworks (GxP, ICH, FDA, EMA, etc.).
Expertise in LMS management, data analysis, and process improvement.
Exceptional communication, stakeholder management, and leadership abilities.
Preferred Attributes: Strategic thinker with a strong commitment to scientific learning and development.
Adaptable and agile in a fast-paced, matrixed organization.
Excellent project management and organizational skills.
Dedicated to fostering innovation, compliance, and continuous improvement through education.
Competencies: Accountability for Results:
Maintain a focus on key strategic objectives and uphold high performance standards while actively leading change.
Strategic Thinking & Problem Solving:
Make decisions considering the long-term impact on customers, patients, employees, and business outcomes.
Patient & Customer Centricity:
Keep a constant focus on the needs of customers and stakeholders.
Impactful Communication:
Communicate clearly and respectfully while influencing all levels to achieve optimal outcomes.
Respectful Collaboration:
Value diverse perspectives and seek partnerships to work towards common goals.
Empowered Development:
Take an active role in fostering professional growth as a business priority.
This position offers a competitive salary range of $164,530.00 to $245,985.00, alongside incentive opportunities. Factors such as job experience and specific skills will influence actual compensation. Our benefit package includes comprehensive medical, dental, vision, prescription coverage, basic life, disability insurance, tuition reimbursement, and a generous 401(k) match, among others. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be considered for employment without regard to any legally protected characteristic. For individuals requiring reasonable accommodations due to a disability in the application process, please reach out directly for support. Be cautious of fraudulent job offers posing as Otsuka representative communications. Otsuka only engages through its official career channels.