PV QA Strategy Director — REMS & CSPV Lead

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 184,240 - 276,360; Full time

Job summary

Daiichi Sankyo US is looking for a Director, PV QA DSI to lead quality assurance strategies within Clinical Safety and Pharmacovigilance. The role involves ensuring compliance with regulatory requirements and actively engaging with internal and external stakeholders to maintain high-quality standards.

The ideal candidate will have extensive experience in PV QA, possess strong leadership skills, and contribute to continuous quality improvement initiatives across the organization.

Qualifications

• 10+ years of experience in PV QA and regulated PV activities.
• Strong understanding of drug development processes.
• Extensive knowledge of international GCP, GVP regulations, FDA, Health Canada, and ICH.
• Excellent verbal and written communication skills.

Responsibilities

• Provide PV QA oversight of the company products.
• Lead PV inspection management activities for regulatory compliance.
• Proactively manage Quality Events and CAPA management.
• Drive strategic PV QA oversight and advisory support.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Communication Skills

Problem Solving

Conflict Resolution

Education

Bachelor's Degree in a scientific or health care discipline

Master's Degree

Job description

Daiichi Sankyo US is looking for a Director, PV QA DSI to lead quality assurance strategies within Clinical Safety and Pharmacovigilance. The role involves ensuring compliance with regulatory requirements and actively engaging with internal and external stakeholders to maintain high-quality standards.

The ideal candidate will have extensive experience in PV QA, possess strong leadership skills, and contribute to continuous quality improvement initiatives across the organization.