
1001 - 5000 Mitarbeiter
💊 Pharmazie
🏥 Gesundheitswesen
🧬 Biotechnologie
Pharmaceuticals • Healthcare • Biotechnology
Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.
🕒 vor 1 Monat
🇺🇸 Vereinigte Staaten – Remote
💵 $107.718 - $161.000 / Jahr
⏰ Vollzeit
🟡 Mittelstufe
🟠 Senior
👔 Manager
👻 Geisterscore 22%
🗣️🇺🇸🇬🇧 Englisch erforderlich
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1001 - 5000 Mitarbeiter
💊 Pharmazie
🏥 Gesundheitswesen
🧬 Biotechnologie
Pharmaceuticals • Healthcare • Biotechnology
Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.
• 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 • Prepare and present supplier quality performance data • Build collaborative relationships with supplier quality personnel • Identify and escalate supplier quality concerns, performance risks, and compliance issues • 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 to ensure 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 supplier performance documentation in TrackWise Digital • 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 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, EU GMP, EudraLex Volume 4, and applicable ICH guidelines (Q7, Q9, and Q10) • Experience participating in supplier audits and supporting risk-based supplier management activities • Strong analytical ability with experience interpreting supplier quality metrics and identifying performance trends • Effective written and verbal communication skills • Strong organizational skills and ability to prioritize multiple assignments
• 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 • Incentive opportunity
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