Senior Manager, Global Supplier & Metrics

Otsuka is seeking a highly motivated, results-driven, and analytical professional to serve as the Senior Manager of Global Supplier Performance & Metrics. Reporting directly to the Associate Director, Global Supplier Performance & Metrics, this role is responsible for driving the day-to-day execution of supplier quality management strategies to ensure the quality, compliance, and reliability of external suppliers supporting Otsuka’s global operations.

The position partners closely with Global Quality, Technical Operations, Supply Chain, and external suppliers to maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements.

• Relationship Execution: Serve as a primary Quality point of contact for assigned critical external suppliers, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs).
• Quality Business Reviews: Support Joint Steering Committees and Business Review Meetings. Deliver and present data-driven quality insights to ensure supplier operational decisions align with GMP compliance and Otsuka standards.
• Collaborative Accountability: Partner directly with supplier quality counterparts to monitor performance, address deviations early, and proactively prevent quality failures.

• Metric Tracking & Dashboarding: Own the day-to-day collection, tracking, and analysis of standardized Global Supplier Quality metrics and KPIs. Maintain performance dashboards.
• Management Reports: Synthesize complex data sets into concise, clear quality performance reports. Draft presentations and updates for the Associate Director to support management-level decision-making.
• Trend Analysis: Monitor data for negative trends in supplier performance, escalating risks to leadership and executing approved mitigation strategies to safeguard global product supply.

• Audit Execution: Coordinate and execute assigned audits within the global supplier audit schedule, ensuring robust evaluation of API manufacturers, drug product CMOs, packaging suppliers, and laboratories.
• Quality Agreements: Assist with the drafting, initial negotiation, and maintenance of global Quality Agreements, ensuring regulatory expectations and roles are clearly defined.
• Track Wise Digital Power User: Act as a hands-on support for Track Wise Digital supplier quality modules. Manage daily utilization including supplier profiles, audit logging, deviations, and CAPA tracking.

• Degree: Bachelor’s degree in a scientific, engineering, or health-related discipline (e.g., Chemistry, Biology, Pharmacy, etc.) is required.
• Industry
  
  Experience:
  
  A minimum of 5 years of progressive experience within the pharmaceutical, biopharmaceutical, or medical device industry, with a strong focus on quality assurance, supplier quality, or CMO management.

• Digital Proficiency: Hands-on experience with Track Wise Digital is strictly required. Must possess deep proficiency in navigating, leveraging, and managing workflows/dashboards within the platform.
• Regulatory Expertise: Knowledge of global GxP regulations (FDA 21 CFR 210/211/11, EU GMP, Eudra Lex Volume 4, ICH guidelines Q7, Q9, Q10).
• Audit Capabilities: Proven track record executing supplier audits as a lead or co-auditor, utilizing risk-based auditing methodologies.

• Analytical
  
  Skills:
  
  Strong capability to compile large data sets, identify systemic trends, and translate metrics into clear, actionable visual reports.
• Communication & Presentation: Excell…