Senior Manager, Global Supplier Performance, Metrics

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Serve as the primary Quality point of contact for assigned critical external suppliers, CMOs, and CDMOs • Support Joint Steering Committees and Business Review Meetings • Present data-driven quality insights aligned with GMP compliance and Otsuka standards • Monitor supplier performance, address deviations early, and proactively prevent quality failures • Collect, track, and analyze Global Supplier Quality metrics and KPIs • Maintain supplier performance dashboards • Synthesize complex data into quality performance reports and management presentations • Monitor negative supplier-performance trends, escalate risks, and execute mitigation strategies • Coordinate and execute assigned supplier audits • Assist with drafting, negotiating, and maintaining global Quality Agreements • Support daily TrackWise Digital supplier-quality operations, including supplier profiles, audit logging, deviations, and CAPA tracking

🎯 Requirements

• Bachelor's degree in a scientific, engineering, or health-related discipline is required • Minimum of 5 years of progressive experience in the pharmaceutical, biopharmaceutical, or medical device industry • Strong focus on quality assurance, supplier quality, or CMO management • Hands-on experience with TrackWise Digital is strictly required • Deep proficiency navigating, leveraging, and managing TrackWise Digital workflows and dashboards • Knowledge of global GxP regulations, including FDA 21 CFR 210/211/11, EU GMP, EudraLex Volume 4, and ICH Q7, Q9, Q10 guidelines • Proven experience executing supplier audits as a lead or co-auditor • Experience utilizing risk-based auditing methodologies • Strong ability to compile large data sets, identify systemic trends, and translate metrics into actionable visual reports • Excellent written and verbal communication skills • Ability to present data summaries and risk assessments to management • Ability to manage difficult conversations with external suppliers while balancing regulatory compliance and collaborative relationships

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term disability insurance • Long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits