Senior / Auditor, Audits and Inspections Program - Canada/US - Remote

Worldwide Clinical Trials; North Carolina; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative global CRO is seeking a Senior Auditor for their Audits and Inspections Program. This remote role focuses on ensuring quality standards through comprehensive audits and supporting regulatory compliance. With a commitment to continuous process improvements, the successful candidate will play a vital role in enhancing operational excellence. Ideal for professionals with extensive GCP and GxP experience, this position offers the opportunity to make a significant impact on patient outcomes while working in a diverse and inclusive environment. Join this forward-thinking organization and be part of a team dedicated to making a difference.

Qualifications

• 5+ years of GCP, GxP experience with a strong understanding of drug development.
• Proficiency in conducting GCP audits and experience with trending and analysis.

Responsibilities

• Adhere to Worldwide’s Quality Management System (QMS).
• Perform various QA audits and report on findings.
• Support sponsor audits and develop training materials.

Skills

GCP Audits

GxP Standards

Regulatory Compliance

Process Improvement

Education

MS in a scientific or health-related field

Job description

Senior / Auditor, Audits and Inspections Program - Canada/US - Remote

Join to apply for the Senior / Auditor, Audits and Inspections Program - Canada/US - Remote role at Worldwide Clinical Trials.

This role involves ensuring quality standards through audits, supporting regulatory compliance, and participating in continuous process improvements within a global CRO environment.

Responsibilities include:

1. Adhering to Worldwide’s Quality Management System (QMS).
2. Performing various QA audits (Vendor, Internal, Investigator, Document).
3. Reporting on audit findings and ensuring CAPA implementation.
4. Supporting sponsor audits and developing training materials.
5. Serving as a Subject Matter Expert on QA processes.

Qualifications:

• 5+ years of GCP, GxP experience, with a strong understanding of drug development and regulatory standards.
• Proficiency in conducting GCP audits and experience with trending and analysis methodologies.
• MS in a scientific or health-related field.
• Minimum 3 years of QA auditing experience.
• Willingness to travel domestically and internationally.

We are committed to diversity and inclusion, offering a supportive environment for professionals from all backgrounds. Join us to make a difference in patients' lives.