[Hiring] Executive Director, R&D Global Quality @Otsuka Pharmaceutical Co., Ltd.

Role Description

We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality.

• Ensure OAPI, OPDC and all affiliates are inspection ready.
• Oversee clinical trial and submission support.
• Lead the R&D audit program.
• Engage with regulatory authorities.
• Maintain clinical data integrity.
• Provide a compelling vision for the R&D Global Quality that aligns with the Global Quality function.
• Oversee R&D Global Quality for Otsuka and partner with business groups and global regions.
• Assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks.

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP).
• Experience and successful interaction within a Japanese company or a multi-national with a Japanese arm.
• Previous experience in the global pharmaceutical and medical device industry.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Exceptional leadership and team development skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Strategic thinking and problem-solving abilities.
• Travel (approximately 30%).

Requirements

• Accountability for Results: Stay focused on key strategic objectives.
• Strategic Thinking & Problem Solving: Make decisions considering long-term impacts.
• Patient & Customer Centricity: Focus on the needs of customers and key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect.
• Respectful Collaboration: Seek and value others’ perspectives.
• Empowered Development: Play an active role in professional development.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.