Senior GxP Auditor & Quality Compliance SME

RxCloud; Oregon (WI); Hybrid; USD 120,000 - 150,000; Full time

Job summary

A biotech quality firm is seeking a GxP Auditor to be part of the Quality and Compliance team. The role includes planning and conducting quality audits, acting as a Subject Matter Expert, and managing auditing deliverables. Candidates should have over 20 years of relevant experience, including 15 years in GxP auditing, and a solid understanding of regulatory requirements. The ideal applicant will enhance stakeholder satisfaction and stay updated on advances in GxP services within the biotech industry.

Qualifications

• Minimum of 20 years of relevant experience.
• Minimum of 15 years of GxP auditing in a regulated environment.
• Excellent knowledge of GxP regulatory requirements.

Responsibilities

• Function as a Quality/GxP auditor for external CDMOs and clinical sites.
• Develop and implement the global audit strategy.
• Conduct risk assessments and develop audit plans.

Skills

GxP auditing

Risk assessment

Root cause analysis

Project management

Collaboration

Quality Management Systems

Education

Bachelor's degree in any scientific discipline

Tools

Electronic Quality Management Systems

Job description

A biotech quality firm is seeking a GxP Auditor to be part of the Quality and Compliance team. The role includes planning and conducting quality audits, acting as a Subject Matter Expert, and managing auditing deliverables. Candidates should have over 20 years of relevant experience, including 15 years in GxP auditing, and a solid understanding of regulatory requirements. The ideal applicant will enhance stakeholder satisfaction and stay updated on advances in GxP services within the biotech industry.