Senior Manager - QA Audit GCP, GLP, GVP

October 16

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Travere Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• The Senior Manager, QA Audit GCP/GLP/GVP is responsible for actively supporting the implementation of quality initiatives and leading related activities. • This position will assist with management of the audit program and partner with key clinical and cross-functional groups for compliance. • Responsibilities include managing audits of clinical vendors, sites, and internal processes, and ensuring continuous quality improvement. • Review clinical documents for compliance with regulations and develop analytics to identify trends.

Requirements

• Bachelor's degree in a scientific discipline is required. • Advanced degree is preferred. • 7+ years in drug/biologics development in the biotechnology or pharmaceutical industry. • Minimum 5 years previous GCP Quality Assurance experience in Clinical Research and Development is preferred. • 4+ years of Quality Assurance auditing experience is required. • In-depth knowledge of and ability to interpret and apply GCP EU, FDA and ICH regulations and guidelines. • Strong working knowledge/experience in planning, conducting, and reporting clinical site and service provider audits. • Experience in GLP auditing a plus. • Ability to identify quality issues/discrepancies and effectively manage and resolve them.

Benefits

• Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents. • Wellness and employee support programs. • Life insurance, disability, retirement plans with employer match and generous paid time off.