Manager, Global Supplier & Metrics

Remote

Full time

R12736

Otsuka is seeking a motivated, detail-oriented, and analytical professional to serve as the Manager, Global Supplier Performance & Metrics. Reporting directly to the Senior Manager, Global Supplier Performance & Metrics, this role is responsible for supporting the execution of supplier quality management activities to ensure the quality, compliance, and performance of external suppliers supporting Otsuka's global operations.

The Manager is responsible for the day-to-day execution of supplier performance monitoring, supplier quality oversight, KPI reporting, audit support, and supplier risk management activities. Working collaboratively with Global Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers, this position helps maintain a robust supplier quality framework aligned with global GMP, GDP, and applicable regulatory requirements.

• Serve as the primary Quality representative for assigned suppliers, including CMOs, CDMOs, laboratories, packaging suppliers, and other GMP service providers.
• Participate in supplier governance meetings, Joint Steering Committees, and Business Review Meetings by preparing and presenting supplier quality performance data.
• Build collaborative working relationships with supplier quality personnel to facilitate timely communication, issue resolution, and continuous improvement.
• Identify and escalation supplier quality concerns, performance risks, and compliance issues to the Senior Manager with recommended actions.

• Collect, maintain, and analyze Global Supplier Quality metrics and key performance indicators.
• Develop and maintain supplier performance dashboards and scorecards supporting routine business reviews.
• Prepare recurring supplier performance reports, trend analyses, and management presentations.
• Monitor supplier performance data for emerging risks and support implementation of approved mitigation activities.

• Support the planning, coordination, and execution of supplier audits for API manufacturers, drug product CMOs, packaging suppliers, and contract laboratories.
• Monitor supplier CAPAs and follow up to ensure timely closure.
• Assist with drafting, revising, and maintaining supplier Quality Agreements.
• Support supplier qualification and ongoing supplier risk assessment activities.

• Serve as a functional user of Track Wise Digital supplier quality modules, maintaining supplier profiles, audit records, deviations, CAPAs, and supplier performance documentation.
• Ensure supplier quality records remain accurate, complete, and inspection-ready.
• Identify opportunities to improve supplier quality processes, reporting, and system utilization.

• Bachelor's degree in a scientific, engineering, or health-related discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) is required.
• Minimum of 3 years of progressive experience within the pharmaceutical, biotechnology, or medical device industry, with experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, or CMO Management.
• Previous experience supporting supplier quality programs, supplier audits, quality systems, or external manufacturing operations is preferred.

• Experience using Track Wise Digital or comparable electronic Quality Management Systems (eQMS) is required.
• Working knowledge of FDA 21 CFR Parts 210, 211, and 11, EU GMP, Eudra Lex Volume 4, and applicable ICH guidelines (Q7, Q9, and Q10).
• Experience participating in supplier audits and supporting risk-based supplier management…