PV QA Director - REMS & CSPV Strategy Lead

Merck & Co.; Basking Ridge (NJ); On-site; USD 184,240 - 276,360; Full time

Job summary

Daiichi Sankyo, Inc. seeks a Director, PV QA DSI to lead the planning and implementation of the Quality Assurance strategy within CSPV in the US.

This role provides operational PV QA involvement and ensures quality oversight of products with REMS, collaborating with Global Audits, Compliance, Development and Medical QA. The incumbent will drive a proactive quality culture, lead cross‑functional teams, and manage PV QA resources in the US, including coaching and performance management, to align

Qualifications

• Bachelor's Degree in scientific, health care or related discipline; Master's degree preferred.
• 10+ years leading PV QA and regulated PV activities in CSPV/PV QA roles.
• Extensive knowledge of GCP, GVP, ICH and related regulations.
• Excellent verbal and written communication, problem-solving and decision‑making skills.
• Ability to influence cross-functional teams and lead groups toward alignment.
• Experience with REMS programs is an advantage.

Responsibilities

• Provide PV QA oversight of CSPV aligned with business strategy.
• Lead PV inspection management activities and ensure readiness for US regulatory inspections.
• Facilitate a structured lessons‑learned framework with audits, inspections, regulatory intelligence and process improvement.
• Provide operational PV QA leadership and guidance to CSPV teams.
• Ensure oversight of Quality Events and CAPA with timely escalation and remediation.
• Mentor and manage PV QA resources in the US.
• Support REMS activities and regulatory submissions review.
• Represent PV QA at governance meetings and drive continuous improvement.

Skills

Verbal communication

Written communication

Problem solving

Decision making

Cross-functional leadership

Influence/leadership

Education

Bachelor's Degree

Master’s Degree preferred

Job description

Daiichi Sankyo, Inc. seeks a Director, PV QA DSI to lead the planning and implementation of the Quality Assurance strategy within CSPV in the US.

This role provides operational PV QA involvement and ensures quality oversight of products with REMS, collaborating with Global Audits, Compliance, Development and Medical QA. The incumbent will drive a proactive quality culture, lead cross‑functional teams, and manage PV QA resources in the US, including coaching and performance management, to align