Manager, Global Supplier Performance – Metrics

🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

💵 $107 718 - $161 000 / an

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 22%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Otsuka Pharmaceutical Companies (U.S.)

Otsuka Pharmaceutical Companies (U.S.)

1001 - 5000 employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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