Director, Global Product Quality – Manufacturing

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $169 222 - $253 000 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 13%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Otsuka Pharmaceutical Companies (U.S.)

Site WebLinkedInTous les Emplois

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

• Responsible for overall Quality and compliance of GMP suppliers providing contract manufacturing, clinical packaging and labeling, distribution, and testing services for Otsuka Small Molecule and Biologics products • Establishes and maintains the effectiveness of Quality Systems for managing the batch record review and disposition processes supporting Commercial Product (API, drug product, and final finished product) • Works to maintain the effectiveness of Quality Management Systems for GMP activities supporting Investigational Medicinal Products and Commercial Product • Leads resolution of product quality issues by driving robust root cause investigations and CAPA implementation and escalates quality issues to senior management when appropriate • Oversees development and maintenance of Standard Operating Procedures, work instructions, forms, templates, and other documents associated with the systems noted above • Ensures Quality Agreements are executed with Suppliers and that the agreements remain in compliance with local and global procedures • Represents global product quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP • Collaborates with project teams supporting key Otsuka projects to assure that goals set by the team as they relate to potential suppliers are consistent with local and global quality objectives and relevant governmental requirements • Serves as Global Quality Product Champion and is responsible for monitoring and escalation of any situation with potential negative impact on clinical study supplies and/or supply chain for commercial product or impact to patients

🎯 Exigences

• Bachelor’s degree in Biology, Chemistry, or related field • Minimum 12 years of combined experience in QA role and/or pharmaceutical manufacturing role, supporting GMP activities for Investigational Medicinal Products or Commercial Products • Thorough understanding of the Drug Development process and cGMP regulatory requirements • Ability to handle interactions and resolve issues with internal customers and GMP Suppliers in a tactful, professional and effective manner • Experience with Small Molecule API and Drug Product manufacturing • Strong analytical problem solving and decision-making skills • Risk Management experience • Position requires approximately 30% domestic travel; Occasional international travel may also be necessary

🏖️ Avantages

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits