PV QA Strategy Director – Global Quality & REMS Oversight

Initial Therapeutics, Inc.; Basking Ridge (NJ); On-site; USD 184,240 - 276,360; Full time

Job summary

Initial Therapeutics, Inc. is seeking a Director, PV QA DSI to lead the Quality Assurance strategy within Clinical Safety and Pharmacovigilance (CSPV). This role will oversee PV QA activities, ensuring compliance with regulatory requirements while leading a high-performing team. Candidates should have 10+ years of experience in PV QA and strong knowledge of international regulations, as well as the ability to foster a culture of excellence.

The position offers competitive compensation, with a salary range of USD$184,240.00 - USD$276,360.00. The ideal candidate will have a proven record of leadership and innovative problem-solving skills.

Qualifications

• 10+ years in PV QA leadership.
• In-depth knowledge of drug development processes.
• Extensive experience with international regulations.

Responsibilities

• Lead PV QA oversight for Daiichi Sankyo products.
• Manage inspection readiness and compliance.
• Develop training frameworks for PV-related functions.

Skills

Leadership

Regulatory Compliance

Problem-Solving

Communication

Education

Bachelor's degree in a scientific or health care discipline

Master’s preferred

Job description

Initial Therapeutics, Inc. is seeking a Director, PV QA DSI to lead the Quality Assurance strategy within Clinical Safety and Pharmacovigilance (CSPV). This role will oversee PV QA activities, ensuring compliance with regulatory requirements while leading a high-performing team. Candidates should have 10+ years of experience in PV QA and strong knowledge of international regulations, as well as the ability to foster a culture of excellence.

The position offers competitive compensation, with a salary range of USD$184,240.00 - USD$276,360.00. The ideal candidate will have a proven record of leadership and innovative problem-solving skills.