Associate Director, Global Quality Operations Job at Otsuka Pharmaceutical, Princeton, NJ

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  • Otsuka Pharmaceutical
  • Princeton, NJ

Job Description

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.

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