Director, GPV Compliance – Business Management, QA

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

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.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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