Senior GxP Compliance Audit Manager

Job is Expired

Location: Nationwide

Compensation: Salary

Staff Reviewed: Thu, Jun 08, 2023

Job Category: Quality Assurance

Remote Level: 100% Remote

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced, Senior Level

Education Level: Some College, Bachelors, Masters

Job Summary

A pharmaceutical company is seeking a Senior GxP Compliance Audit Manager.

Position Responsibilities

Prepare and lead complex audits across GLP and GCP operations, including internal sites and third parties (domestic and international)
Conduct GCLP audits of non-clinical and clinical study reports, central and specialty laboratories (CLIA and CAP)
Lead pre-audit meetings with internal stakeholders to determine current vendor status and review pre-audit documentation

Required Qualifications

Bachelor's Degree with a life science focus, Advanced Degree (Masters) in a scientific discipline a plus
Extensive knowledge of GCP/GLP regulations with 10+ years of experience within a regulated healthcare industry
Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality - Certified Quality Auditor)
Working knowledge of FDA Regulations, EU GLP, and local country regulations
Able to work independently and be flexible to changing priorities

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Job is Expired

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