Associate Director, Global Quality Operations

Otsuka Pharmaceutical Co., Ltd.

7d

About The Position

Job Summary The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals. Job Description Operational Excellence Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance. Identify and implement best practices, metrics, and tools to drive performance and accountability. Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment. Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives. Risk Management Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles. Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning. Monitor and report on key risk indicators and escalate critical risks to senior leadership. Global Quality System Processes Oversee the design, implementation, and maintenance of global quality system processes (e.g., deviation management, CAPA, change control, document management) guided by process excellence principles. Ensure harmonization and standardization of quality processes across sites and regions. Support quality system enhancements and digital transformation initiatives, ensuring they are informed by robust business process design and governance practices. Compliance & Governance Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards. Support internal audits and regulatory inspections, including readiness activities and remediation. Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement. Leadership & Collaboration Serve as a technical leader within a matrixed organization. Collaborate with Supply Chain, Regulatory Affairs, IT, and other functions to ensure integrated quality operations. Align process improvement initiatives with strategic goals and support leadership in prioritizing efforts that deliver the greatest organizational impact. Represent Quality Operations in global forums and strategic planning initiatives.

Requirements

• Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
• 8+ years of experience in pharmaceutical quality operations, with exposure to both small molecule and biologics.
• Strong knowledge of GxP regulations, quality systems, and risk management principles.
• Proven experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma).
• Excellent communication, leadership, and project management skills.
• Ability to work in a global, matrixed environment and manage multiple priorities.

Nice To Haves

• Experience with global quality systems platforms (e.g., Veeva, TrackWise).
• Familiarity with digital transformation and data analytics in quality operations.
• Prior involvement in regulatory inspections and audit readiness.

Responsibilities

• Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance.
• Identify and implement best practices, metrics, and tools to drive performance and accountability.
• Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment.
• Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives.
• Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles.
• Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning.
• Monitor and report on key risk indicators and escalate critical risks to senior leadership.
• Oversee the design, implementation, and maintenance of global quality system processes (e.g., deviation management, CAPA, change control, document management) guided by process excellence principles.
• Ensure harmonization and standardization of quality processes across sites and regions.
• Support quality system enhancements and digital transformation initiatives, ensuring they are informed by robust business process design and governance practices.
• Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards.
• Support internal audits and regulatory inspections, including readiness activities and remediation.
• Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement.
• Serve as a technical leader within a matrixed organization.
• Collaborate with Supply Chain, Regulatory Affairs, IT, and other functions to ensure integrated quality operations.
• Align process improvement initiatives with strategic goals and support leadership in prioritizing efforts that deliver the greatest organizational impact.
• Represent Quality Operations in global forums and strategic planning initiatives.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees