Global GxP Audit Leader for Quality Assurance

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

Job summary

Daiichi Sankyo, Inc. in New Jersey seeks an Senior GxP Audit Leader who will oversee the end-to-end GxP audit program across the US and collaborate with teams in Europe, Asia, and Latin America to ensure regulatory compliance.

You will drive CAPA development and effectiveness, manage CAPA metrics, and support FDA/EU inspections, with a focus on continuous improvement and cross-functional leadership in QA and clinical development.

Qualifications

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required.
• 10+ years in Quality and clinical development in pharma with global leadership experience.
• Willingness to travel up to 30% domestically and internationally.

Responsibilities

• Oversee the GxP Audit Program across US and collaborate with regional teams to ensure regulatory compliance.
• Lead CAPA governance, track CAPA metrics, and ensure timely closure of corrective actions.
• Support inspection readiness for FDA/EU inspections and alignment with QA counterparts globally.
• Provide QA leadership across multiple functions and drive continuous improvement of GxP processes.

Skills

Leadership

GxP Regulation

Audit Program Management

CAPA Management

Cross-functional Collaboration

Education

Bachelor's Degree in Life Sciences

Master's Degree or higher preferred

Tools

QMS software

Job description

Daiichi Sankyo, Inc. in New Jersey seeks an Senior GxP Audit Leader who will oversee the end-to-end GxP audit program across the US and collaborate with teams in Europe, Asia, and Latin America to ensure regulatory compliance.

You will drive CAPA development and effectiveness, manage CAPA metrics, and support FDA/EU inspections, with a focus on continuous improvement and cross-functional leadership in QA and clinical development.