QA Compliance Specialist

Job Summary

A company is looking for a QA Senior Compliance Specialist with extensive experience in a regulated environment.

Key Responsibilities

• Conducts inspections/audits and hosts external audits/inspections, facilitating audit responses and training
• Leads the generation of global QA policies and provides subject matter expertise on regulatory topics
• Manages global Quality initiatives to improve compliance and efficiency within the QA organization

Required Qualifications

• Bachelor's Degree in Pharmacy, Chemistry, or Biology; postgraduate degree preferred
• 8 years of experience in a regulatory environment, specifically in GxP roles
• Detailed knowledge of specific regulations and extensive experience with FDA and EPA agencies
• Strong ability to navigate root cause analysis and responses to regulatory bodies
• Experience may be substituted for education