Senior GxP Quality, Compliance & Audit Leader

Evinova; Durham (NC); Hybrid; USD 90,000 - 120,000; Full time

Job summary

A growing health-tech organization based in North Carolina is seeking a GxP Quality, Compliance and Audit Associate Director to lead quality management and compliance in clinical trial solutions. The successful candidate will have over 5 years of experience in the pharmaceutical industry, ensuring regulatory alignment and driving innovative practices. This role includes responsibilities such as developing quality management systems, conducting audits, and collaborating across functions. Join us in transforming healthcare through digital innovation.

Qualifications

• 5+ years of experience in the pharmaceutical, biotech, or medical device industry.
• Experience supporting Health Authority inspections.
• Hands-on experience conducting GxP audits.

Responsibilities

• Lead the development of Evinova’s Quality Management System.
• Provide GCP expertise across the software development lifecycle.
• Oversee supplier and third-party qualification and audit activities.

Skills

GCP expertise

Strong knowledge of global GxP regulations

Quality Management System development

Experience in audits

Education

Bachelor’s degree in Life Sciences or related field

Job description

A growing health-tech organization based in North Carolina is seeking a GxP Quality, Compliance and Audit Associate Director to lead quality management and compliance in clinical trial solutions. The successful candidate will have over 5 years of experience in the pharmaceutical industry, ensuring regulatory alignment and driving innovative practices. This role includes responsibilities such as developing quality management systems, conducting audits, and collaborating across functions. Join us in transforming healthcare through digital innovation.