Senior Director, Global Quality Solutions

Job Description

• Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality’s processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.

• The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.

• The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state‑of‑the‑art data insights.

• The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka’s Quality Knowledge and Document Management practices to a best in class – digitalized landscape.

• Develop a roadmap to drive Knowledge Management to an automated, digitized and ever‑green environment

• Digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.

• Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions.

• Addressing digitization of paper documents across the ecosystem of GQ to enable e‑archiving and e‑access and retrievability.

• Design and employ a digital and automated GQ work‑flow across the enterprise of the GQ business function.

• Drive a culture of Quality Innovation awareness.

• Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.

• Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.

• Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well‑defined business cases, clear value proposition, the management of applicable collaborators and identification‑/leveraging of applicable external expertise.

• Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.

• Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.

• Travel (approximately 10‑25%)

• Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 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 credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka’s partners and clinical trial personnel.

• Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science,…