Associate Director, Global Quality Operations

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.

Qualifications

Required

• 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.

Preferred

• 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.

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 - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine