Senior Director, Global Quality Strategy & Operations

Job Summary

The Senior Director of Quality Strategy and Operations will be responsible for developing and delivering the Global Quality strategic plan, overseeing annual objectives, managing the budget, and ensuring the effectiveness of global systems. This role will also encompass document management, learning and development, risk management, data integrity and process excellence. The ideal candidate will have a strong background in quality management within the pharmaceutical industry and a proven track record of driving strategic initiatives.

Job Description

• Quality Strategic Plan: Develop, implement and maintain a comprehensive Global Quality strategic plan aligned with the company’s overall business objectives.
• Annual Objectives: Set and monitor annual Quality objectives, ensuring alignment with strategic goals and business requirements.
• Budget Management: Oversee the Quality department’s budget, ensuring efficient allocation of resources and cost-effective operations, including resource utilization and optimization
• Global Systems: Manage and optimize global Quality systems to ensure compliance, efficiency, and continuous improvement. Establish and maintain best practices for system qualification and validation.
• Document Management: Oversee the document management system, ensuring accurate and timely documentation of all Quality-related activities.
• Learning & Development: Implement and maintain a company-wide learning Center of Excellence.  Implement and maintain training programs to ensure GXP and compliance standards across the global organization.  Enhance the skills and knowledge of the Quality team in line with the business and strategic plans.
• Dashboards and Metrics: Design and maintain dashboards and metrics to monitor Quality performance and drive data-driven decision-making.  Maintain risk management toolkit and best practices.
• Process Improvements: Identify and implement process improvements to enhance Quality operations and achieve operational excellence.
• Data Integrity Management: Establish and maintain data integrity policies, procedures, and guidelines. Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GxP, ISO). Conduct regular audits and assessments to identify and mitigate data integrity risks.
• Operational Excellence: Develop, implement and lead centers of excellence, as appropriate and in alignment with business goals.  Bring industry best practices, process optimization, continuous improvement and governance to areas such as training and audit.  Foster a culture of operational excellence, ensuring best practices are followed and continuous improvement is achieved.  Maintain oversight for a process improvement portfolio.
• Talent Management:  Effectively manage and develop team members, ensuring they are engaged, skilled, and aligned with the organization’s strategic objectives.  This includes, objective oversight, development plans, regular feedback and coaching, skill development, and succession planning.

Qualifications

- Bachelor degree required, advanced degree preferred with a minimum of 15 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka’s partners, and clinical trial personnel credibly, knowledgeably, and effectively.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka’s competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative, and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.

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 -