Regulatory Compliance Auditor – Life Sciences

Weltraw Consulting Group; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Weltraw Consulting Group seeks an experienced Quality/Compliance professional to support FDA audit readiness. The role focuses on performing gap analyses, mock audits, and remediation activities to prepare clients for inspections.

Responsibilities include reviewing SOPs, assisting with CAPAs, and conducting data integrity investigations. Travel to client sites (up to 25%) is expected, with collaboration across life sciences clients and regulatory teams.

Qualifications

• 5+ years in Quality or Compliance in Life Sciences.
• CQA certification preferred.
• Experience with Data Integrity remediation projects.
• Willingness to travel to client sites up to 25%.

Responsibilities

• Conduct mock audits and gap assessments against regulatory standards.
• Assist clients in remediating audit findings and CAPAs.
• Review SOPs and Policies for compliance gaps.
• Support data integrity investigations.

Skills

Quality Assurance

Regulatory Compliance

Data Integrity

Travel Readiness

Job description

About The Role

About the Role

Join our Regulatory Services team to help clients navigate the complex landscape of FDA audits. You will perform gap analyses and prepare clients for upcoming inspections.

Key Responsibilities

• Conduct mock audits and gap assessments against regulatory standards.
• Assist clients in remediating audit findings and CAPAs.
• Review SOPs and Policies for compliance gaps.
• Support data integrity investigations.
  
  

Requirements

• 5+ years in a Quality or Compliance role within Life Sciences.
• Certified Quality Auditor (CQA) preferred.
• Experience with Data Integrity remediation projects.
• Ability to travel to client sites (up to 25%).