Global GxP Audit Director, Quality Assurance

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 202,000 - 303,000; Full time

Job summary

Daiichi Sankyo in the United States seeks a senior leader to head Global GxP Audits. You will report to the Head, Global GxP Audits, coordinating with teams in Europe, Asia and Latin America.

You will oversee end-to-end GxP audits, CAPA management, and inspection readiness to maintain regulatory compliance across the organization. The role emphasizes developing CAPA metrics, driving continuous improvement, and partnering with QA and clinical teams to support pre-approval inspections and

Qualifications

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required. A Master's Degree or other advanced degree preferred.
• 10+ years of experience in Quality and clinical development in the pharmaceutical industry, with global/matrix leadership experience.

Responsibilities

• Oversee the GxP Audit Program to align with DSG priorities and regulatory expectations.
• Coordinate with audit program for clinical studies across GxP groups, affiliates, and vendors.
• Ensure Annual Audit Plans align with strategy and are executed using a risk-based approach.
• Lead and mentor direct reports to deliver the audit plan effectively.
• Support quality metrics for audits and inspections and report findings to management.
• Provide inspection readiness support for FDA/EU/HA inspections and CAPA follow-up.

Skills

Leadership

GxP Audits

Global collaboration

Education

Bachelor's Degree in Life Sciences, Pharmacy or Medicines

Job description

Daiichi Sankyo in the United States seeks a senior leader to head Global GxP Audits. You will report to the Head, Global GxP Audits, coordinating with teams in Europe, Asia and Latin America.

You will oversee end-to-end GxP audits, CAPA management, and inspection readiness to maintain regulatory compliance across the organization. The role emphasizes developing CAPA metrics, driving continuous improvement, and partnering with QA and clinical teams to support pre-approval inspections and