
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.
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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.
• Serve as the primary Quality representative for assigned 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 relationships with supplier quality personnel to facilitate communication, issue resolution, and continuous improvement • Identify and escalate supplier quality concerns, performance risks, and compliance issues with recommended actions • Collect, maintain, and analyze Global Supplier Quality metrics and KPIs • Develop and maintain supplier performance dashboards and scorecards • Prepare recurring supplier performance reports, trend analyses, and management presentations • Monitor supplier performance data for emerging risks and support mitigation activities • Support planning, coordination, and execution of supplier audits • Monitor supplier CAPAs and follow up for timely closure • Assist with drafting, revising, and maintaining supplier Quality Agreements • Support supplier qualification and ongoing supplier risk assessment activities • Maintain supplier profiles, audit records, deviations, CAPAs, and performance documentation in TrackWise Digital • Ensure supplier quality records are 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 is required • Minimum of 3 years of progressive experience within the pharmaceutical, biotechnology, or medical device industry • Experience in Quality Assurance, Supplier Quality, External Manufacturing Quality, or CMO Management • Experience using TrackWise Digital or comparable electronic Quality Management Systems (eQMS) is required • Working knowledge of FDA 21 CFR Parts 210, 211, and 11 • Working knowledge of EU GMP and EudraLex Volume 4 • Working knowledge of applicable ICH guidelines Q7, Q9, and Q10 • Experience participating in supplier audits • Experience supporting risk-based supplier management activities • Strong analytical ability interpreting supplier quality metrics and identifying performance trends • Effective written and verbal communication skills • Ability to prepare clear reports and present findings to cross-functional teams • Ability to build productive working relationships with internal stakeholders and external suppliers • Strong organizational skills and ability to prioritize multiple assignments • Ability to support continuous improvement initiatives
• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and 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
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