Associate Director of Good Practice Training
Otsuka America Pharmaceutical Inc., Indianapolis, Indiana, us, 46262
The Associate Director of Good Practice (GxP) Training plays a vital role in the Learning Center of Excellence within Global Quality. This position is essential for crafting and sustaining effective training programs that uphold compliance with GxP regulations across the organization. As a leader in this role, you will be responsible for designing, implementing, and governing global learning strategies that promote regulatory preparedness, operational excellence, and a robust quality culture.
Key Responsibilities
Learning Strategy & Governance
Develop and execute a comprehensive global GxP training strategy aligned with regulatory requirements and corporate quality goals. Establish robust governance frameworks for training compliance, encompassing policies, procedures, and ensuring audit readiness.
Program Development & Delivery
Design and manage GxP training programs for various functions including R&D, Manufacturing, Quality, Clinical, and Commercial. Create innovative learning solutions utilizing adult learning principles, digital platforms, and blended learning methods.
Compliance & Risk Management
Ensure all training programs comply with global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. Monitor training compliance metrics and proactively identify and address gaps to minimize regulatory risk.
Stakeholder Collaboration
Collaborate with functional leaders, Quality Systems, and HR to align training initiatives with business objectives. Serve as a subject matter expert on GxP learning during audits and inspections.
Continuous Improvement & Analytics
Define key performance indicators (KPIs) and leverage data analytics to evaluate training effectiveness, driving continuous enhancement of programs. Stay informed about regulatory changes, industry trends, and emerging technologies to evolve training initiatives.
Qualifications Required: Bachelor's degree; 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 sectors focusing on GxP compliance. Strong grasp of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). Demonstrated ability to design and implement impactful learning programs using adult learning principles. Familiarity with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. Expertise in instructional design and digital learning technologies. Outstanding communication, stakeholder management, and project leadership capabilities. Preferred Attributes Strategic thinker passionate about scientific learning and development. Agile and adaptable in a dynamic, matrixed environment. Strong project management and organizational skills. Committed to fostering innovation, compliance, and continuous improvement through learning. Competencies Accountability for Results:
Remain focused on key strategic objectives while ensuring high performance standards. Strategic Thinking & Problem Solving:
Make decisions considering long-term impacts on customers, patients, employees, and the business. Patient & Customer Centricity:
Prioritize the needs of our customers and key stakeholders. Impactful Communication:
Communicate effectively to influence at all levels for optimal results. Respectful Collaboration:
Value diverse perspectives and cultivate partnerships to achieve shared goals. Empowered Development:
Actively engage in professional growth as a business imperative. Compensation The salary range for this position is $146,955.00 to $219,650.00, including an incentive opportunity. Actual pay may vary based on job experience, specific skills, and internal comparisons. Company Benefits We offer comprehensive medical, dental, and vision coverage, basic life insurance, disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and various other benefits. Join us and learn more about the exciting opportunities at Otsuka. Disclaimer This job description is designed to outline the general nature and level of work for those assigned to this position and does not encompass every responsibility. Otsuka maintains the right to amend and change responsibilities based on business needs. Fraud Warning Otsuka emphasizes the protection of your personal information during the recruitment process. Be cautious of fraudulent individuals posing as Otsuka representatives offering fictitious job opportunities. Otsuka will never request financial information or payments during the application process. If such requests occur, it is not a legitimate Otsuka communication. For verified job opportunities, please communicate directly through our official Otsuka Career website. Otsuka is an equal opportunity employer, welcoming all qualified applicants without discrimination.
Develop and execute a comprehensive global GxP training strategy aligned with regulatory requirements and corporate quality goals. Establish robust governance frameworks for training compliance, encompassing policies, procedures, and ensuring audit readiness.
Program Development & Delivery
Design and manage GxP training programs for various functions including R&D, Manufacturing, Quality, Clinical, and Commercial. Create innovative learning solutions utilizing adult learning principles, digital platforms, and blended learning methods.
Compliance & Risk Management
Ensure all training programs comply with global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. Monitor training compliance metrics and proactively identify and address gaps to minimize regulatory risk.
Stakeholder Collaboration
Collaborate with functional leaders, Quality Systems, and HR to align training initiatives with business objectives. Serve as a subject matter expert on GxP learning during audits and inspections.
Continuous Improvement & Analytics
Define key performance indicators (KPIs) and leverage data analytics to evaluate training effectiveness, driving continuous enhancement of programs. Stay informed about regulatory changes, industry trends, and emerging technologies to evolve training initiatives.
Qualifications Required: Bachelor's degree; 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 sectors focusing on GxP compliance. Strong grasp of R&D functions and the regulatory landscape (GxP, ICH, FDA, EMA, etc.). Demonstrated ability to design and implement impactful learning programs using adult learning principles. Familiarity with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training strategies. Expertise in instructional design and digital learning technologies. Outstanding communication, stakeholder management, and project leadership capabilities. Preferred Attributes Strategic thinker passionate about scientific learning and development. Agile and adaptable in a dynamic, matrixed environment. Strong project management and organizational skills. Committed to fostering innovation, compliance, and continuous improvement through learning. Competencies Accountability for Results:
Remain focused on key strategic objectives while ensuring high performance standards. Strategic Thinking & Problem Solving:
Make decisions considering long-term impacts on customers, patients, employees, and the business. Patient & Customer Centricity:
Prioritize the needs of our customers and key stakeholders. Impactful Communication:
Communicate effectively to influence at all levels for optimal results. Respectful Collaboration:
Value diverse perspectives and cultivate partnerships to achieve shared goals. Empowered Development:
Actively engage in professional growth as a business imperative. Compensation The salary range for this position is $146,955.00 to $219,650.00, including an incentive opportunity. Actual pay may vary based on job experience, specific skills, and internal comparisons. Company Benefits We offer comprehensive medical, dental, and vision coverage, basic life insurance, disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and various other benefits. Join us and learn more about the exciting opportunities at Otsuka. Disclaimer This job description is designed to outline the general nature and level of work for those assigned to this position and does not encompass every responsibility. Otsuka maintains the right to amend and change responsibilities based on business needs. Fraud Warning Otsuka emphasizes the protection of your personal information during the recruitment process. Be cautious of fraudulent individuals posing as Otsuka representatives offering fictitious job opportunities. Otsuka will never request financial information or payments during the application process. If such requests occur, it is not a legitimate Otsuka communication. For verified job opportunities, please communicate directly through our official Otsuka Career website. Otsuka is an equal opportunity employer, welcoming all qualified applicants without discrimination.