GCP Auditor - Remote

Overview

As a GCP Auditor, you will play a key role in the Internal Audit and CAPA Management Programs and serve as the lead for Sponsor and Vendor Audit activities, quality metrics compilation, analysis, trending and reporting, and facilitation of, issues escalated to leadership, as well as Quality Improvement activities.

In Short

• Client Audit Hosting and Internal Audit activities, including follow up on the resulting actions
• Complete Internal audit activities related to Delivery and Process audits
• Ownership of managing the Quality Management System process gaps and needed improvements focused on the Services Organization
• Work collaboratively across various functional organizations including India Operations
• Inform senior management of any non-compliance incidents or regulatory compliance issues
• Remain abreast of and apply updates to regulations, guidelines, and principles related to Good Clinical Practice
• Work with company compliance experts by identifying quality issues and trends
• Assist in the review and approval of QMS procedures
• Other duties as assigned

Requirements

• Bachelor’s degree or equivalent work experience preferred
• 5+ years Pharmaceutical/Biotechnology industry or equivalent experience preferred
• 3+ years of experience in a GCP Quality or Operational role
• Certified Quality Auditor Certification or equivalent experience preferred
• Experience drafting, editing, and reviewing GCP SOPs and WIs
• Experience maintaining a QMS for the management of controlled documents, training, deviation, CAPA and audit management is a strong plus

Benefits

• Accelerate your skills and career within a fast-growing company
• Impact the future of healthcare
• Inclusive culture that values diversity
• Opportunities to learn, grow and continuously improve
• Equal opportunity employer