Director, GPV Compliance – Business Management, QA

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Develop and execute the compliance strategy for GPV functional areas, collaborating with Global Quality Management and internal partners.

• Facilitate cross-functional teamwork with affiliates, Otsuka companies, external pharmaceutical entities, and internal groups.

• Manage activities across Compliance & Business Management sub-functions.

• Supervise the external vendor that supports GPV compliance efforts.

• Direct global pharmacovigilance audit and inspection readiness across various regions.

• Lead the strategy, governance, and execution of GxP regulatory inspections that impact pharmacovigilance.

• Oversee the planning and coordination of Global Quality audits that affect affiliates, global PV processes, and alliance activities.

• Govern the audit activities of alliance companies and Global Service Providers regarding PV.

• Interface with inspectorates, regulatory bodies, industry associations, and inter-company networks.

• Offer escalation assistance to Local Safety Managers during PV audits and inspections.

• Drive planning for readiness and post-inspection remediation, including oversight of CAPA.

• Manage audit and inspection governance for partner companies.

• Lead training initiatives that support inspection readiness and foster a PV quality culture.

• Drive enterprise-wide optimization of PV processes and continuous improvement efforts.

• Oversee root cause analyses and investigations related to non-compliance with PV requirements.

• Govern the development, prioritization, tracking, review, and closure of PV CAPA.

• Supervise PV Deviations, Temporary Change Controls, and Standalone CAPAs.

• Conduct governance meetings with Global Quality.

• Present compliance metrics at Global Meetings.

• Contribute to the PV System Master File.

• Collaborate with Regional PV offices to enhance processes and implement corrective and preventive actions.

• Lead or support special projects and process development initiatives.

• Manage direct reports when assigned.

⛳️ Requirements

• A bachelor's degree is required.

• At least 6 years of experience in PV Compliance or Quality Management within the pharmaceutical industry, or equivalent leadership experience.

• Experience in a global environment.

• Proven experience in managing vendor relationships and oversight.

• In-depth knowledge of ICH, US, and EU pharmacovigilance regulations and requirements.

• Strong background in pharmaceutical quality system management (GxP).

• Experience in coordinating and/or participating in pharmacovigilance audits in the pharmaceutical sector.

• Excellent project management, interpersonal, communication, and presentation skills.

• Capability to achieve objectives through influence within a matrix organization.

• Proficient computer skills in Word, Excel, PowerPoint, and Outlook.

• Experience with GVP and GCP.

• Familiarity with inspections conducted by FDA, MHRA, and similar agencies.

• Experience with quality compliance management systems.

• Microsoft proficiency is 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.