Associate Director of GxP Training Excellence (Boston)
Otsuka America Pharmaceutical Inc., Boston, Massachusetts, United States, 02298
The Associate Director of GxP Training Excellence is a pivotal leader within our Learning Center of Excellence in Global Quality. This role is crucial for developing and maintaining dynamic training programs that ensure compliance with GxP regulations throughout the organization. As a driving force behind learning strategies, you will foster regulatory preparedness, enhance operational excellence, and cultivate a strong quality culture.
Key Responsibilities
Learning Strategy & Governance
Design and implement a comprehensive global GxP training strategy that aligns with regulatory mandates and corporate quality objectives. Establish strong governance frameworks for training compliance, including policies, procedures, and maintaining audit readiness.
Program Development & Delivery
Create and oversee GxP training initiatives across key functions such as R&D, Manufacturing, Quality, Clinical, and Commercial. Develop innovative learning solutions utilizing adult learning principles, digital platforms, and blended learning methodologies.
Compliance & Risk Management
Guarantee that all training programs adhere to global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. Track training compliance metrics and proactively identify and address gaps to reduce regulatory risk.
Stakeholder Collaboration
Work closely with functional leaders, Quality Systems, and HR to synchronize training initiatives with business goals. Act as a subject matter expert on GxP learning during audits and inspections.
Continuous Improvement & Analytics
Set key performance indicators (KPIs) and utilize data analytics to assess training effectiveness, aiming for the ongoing improvement of programs. Keep abreast of regulatory changes, industry trends, and new technologies to enhance training initiatives.
Qualifications Required: Bachelor’s degree; advanced degree in Life Sciences, Education, Organizational Development, or a related field is preferred. 8+ years of experience in learning and development, ideally within the pharmaceutical, biotech, or healthcare sectors with an emphasis on GxP compliance. Strong understanding of R&D functions and the regulatory environment (GxP, ICH, FDA, EMA, etc.). Proven ability to design and implement impactful learning programs utilizing adult learning principles. Familiarity with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training approaches. Expertise in instructional design and digital learning tools. Exceptional communication, stakeholder management, and project leadership 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 abilities. Dedicated to fostering innovation, compliance, and continuous improvement through learning. Competencies Accountability for Results:
Focus on achieving key strategic objectives while upholding high performance standards. Strategic Thinking & Problem Solving:
Make decisions with long-term impacts on customers, patients, employees, and the business in mind. Patient & Customer Centricity:
Prioritize the needs of our customers and key stakeholders. Impactful Communication:
Communicate effectively to influence stakeholders at all levels for optimal outcomes. Respectful Collaboration:
Value diverse viewpoints and foster partnerships to achieve common goals. Empowered Development:
Actively engage in professional growth as a core business commitment. Compensation The salary range for this position is $146,955.00 to $219,650.00, with an incentive opportunity. Actual pay may vary based on experience, specific skills, and internal comparisons. Company Benefits We offer a comprehensive benefits package including 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 a variety of other benefits. Join us and discover the exciting opportunities at Otsuka. Disclaimer This job description outlines the general nature and level of work for those assigned to this role and does not cover every responsibility. Otsuka reserves the right to amend and modify duties based on business needs. Fraud Warning Otsuka is committed to protecting your personal information throughout the recruitment process. Be aware of individuals fraudulently posing as Otsuka representatives offering false job opportunities. Otsuka will never request financial information or payments during the application process. If you receive such requests, they are not legitimate communications from Otsuka. For verified job opportunities, please visit our official Otsuka Career website. Otsuka is an equal opportunity employer, welcoming all qualified applicants without discrimination.
Design and implement a comprehensive global GxP training strategy that aligns with regulatory mandates and corporate quality objectives. Establish strong governance frameworks for training compliance, including policies, procedures, and maintaining audit readiness.
Program Development & Delivery
Create and oversee GxP training initiatives across key functions such as R&D, Manufacturing, Quality, Clinical, and Commercial. Develop innovative learning solutions utilizing adult learning principles, digital platforms, and blended learning methodologies.
Compliance & Risk Management
Guarantee that all training programs adhere to global regulatory standards (FDA, EMA, ICH, etc.) and internal SOPs. Track training compliance metrics and proactively identify and address gaps to reduce regulatory risk.
Stakeholder Collaboration
Work closely with functional leaders, Quality Systems, and HR to synchronize training initiatives with business goals. Act as a subject matter expert on GxP learning during audits and inspections.
Continuous Improvement & Analytics
Set key performance indicators (KPIs) and utilize data analytics to assess training effectiveness, aiming for the ongoing improvement of programs. Keep abreast of regulatory changes, industry trends, and new technologies to enhance training initiatives.
Qualifications Required: Bachelor’s degree; advanced degree in Life Sciences, Education, Organizational Development, or a related field is preferred. 8+ years of experience in learning and development, ideally within the pharmaceutical, biotech, or healthcare sectors with an emphasis on GxP compliance. Strong understanding of R&D functions and the regulatory environment (GxP, ICH, FDA, EMA, etc.). Proven ability to design and implement impactful learning programs utilizing adult learning principles. Familiarity with learning technologies (e.g., LMS, virtual learning platforms) and data-driven training approaches. Expertise in instructional design and digital learning tools. Exceptional communication, stakeholder management, and project leadership 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 abilities. Dedicated to fostering innovation, compliance, and continuous improvement through learning. Competencies Accountability for Results:
Focus on achieving key strategic objectives while upholding high performance standards. Strategic Thinking & Problem Solving:
Make decisions with long-term impacts on customers, patients, employees, and the business in mind. Patient & Customer Centricity:
Prioritize the needs of our customers and key stakeholders. Impactful Communication:
Communicate effectively to influence stakeholders at all levels for optimal outcomes. Respectful Collaboration:
Value diverse viewpoints and foster partnerships to achieve common goals. Empowered Development:
Actively engage in professional growth as a core business commitment. Compensation The salary range for this position is $146,955.00 to $219,650.00, with an incentive opportunity. Actual pay may vary based on experience, specific skills, and internal comparisons. Company Benefits We offer a comprehensive benefits package including 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 a variety of other benefits. Join us and discover the exciting opportunities at Otsuka. Disclaimer This job description outlines the general nature and level of work for those assigned to this role and does not cover every responsibility. Otsuka reserves the right to amend and modify duties based on business needs. Fraud Warning Otsuka is committed to protecting your personal information throughout the recruitment process. Be aware of individuals fraudulently posing as Otsuka representatives offering false job opportunities. Otsuka will never request financial information or payments during the application process. If you receive such requests, they are not legitimate communications from Otsuka. For verified job opportunities, please visit our official Otsuka Career website. Otsuka is an equal opportunity employer, welcoming all qualified applicants without discrimination.