Quality Assurance Manager

Join to apply for the Quality Assurance Manager role at Technical Resources International, Inc.

Join to apply for the Quality Assurance Manager role at Technical Resources International, Inc.

• Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance.
• Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations.
• Reviews clinical audit reports and provides guidance to auditors.
• Supports inspection readiness program.
• Serves as a subject matter expert for quality.
• Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
• Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations.
• Supports regulatory authority inspection.
  

Job Description

• Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance.
• Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations.
• Reviews clinical audit reports and provides guidance to auditors.
• Supports inspection readiness program.
• Serves as a subject matter expert for quality.
• Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
• Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations.
• Supports regulatory authority inspection.
  

Job Requirements

• Experience working in Quality Assurance GCP internal and client audits (minimum 5 years).
• Experience working with eQMS.
• Proficiency in MS Office.
• Experience with supervising staff.
• Travel 25% (local, domestic, and international).
• Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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