Director, GPV Compliance – Business Management, QA

🔥 5 horas atrás

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $186.489 - $278.875 / ano

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• Define and implement the compliance strategy for GPV functional areas in collaboration with Global Quality Management and internal stakeholders • Lead cross-functional collaboration with affiliates, Otsuka companies, external pharmaceutical organizations, and internal teams • Coordinate activities across Compliance & Business Management sub-functions • Lead and oversee the external vendor supporting GPV compliance activities • Lead global pharmacovigilance audit and inspection preparedness across regions • Direct strategy, governance, and execution of GxP regulatory inspections affecting pharmacovigilance • Oversee planning and coordination of Global Quality audits affecting affiliates, global PV processes, and alliance activities • Govern alliance company and Global Service Provider PV audit activities • Liaise with inspectorates, regulatory agencies, industry associations, and inter-company networks • Provide escalation support to Local Safety Managers for PV audits and inspections • Drive readiness planning and post-inspection remediation, including CAPA oversight • Oversee audit and inspection governance for collaborating companies • Guide training programs supporting inspection readiness and PV quality culture • Lead enterprise-wide PV process optimization and continuous improvement initiatives • Oversee root cause analyses and investigations into non-adherence to PV requirements • Govern PV CAPA development, prioritization, tracking, review, and closure • Oversee PV Deviations, Temporary Change Controls, and Standalone CAPAs • Lead governance meetings with Global Quality • Present compliance metrics at Global Meetings • Contribute to the PV System Master File • Collaborate with Regional PV offices on process improvements and corrective and preventive actions • Lead or assist with special projects and process development • Manage direct reports when assigned

🎯 Requisitos

• Bachelor's degree required • Minimum 6 years of PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience • Experience working in a global setting • Experience managing vendor relationships and oversight • Knowledge of ICH, US, and EU pharmacovigilance regulations and requirements • Solid background and experience in pharmaceutical quality system management (GxP) • Experience coordinating and/or participating in pharmacovigilance audits in the pharmaceutical industry • Strong project management, interpersonal, communication, and presentation skills • Ability to accomplish objectives through influence in a matrix organization • Strong computer skills with Word, Excel, PowerPoint, and Outlook • Experience with GVP and GCP • Experience with inspections conducted by FDA, MHRA, and similar agencies • Experience with quality compliance management systems • Microsoft proficiency essential

🏖️ Benefícios

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death & 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