Associate Director, Quality Compliance

Job Summary

A company is looking for an Associate Director, Global Quality Compliance.

Key Responsibilities

• Provide compliance oversight for late-stage projects to ensure adherence to regulations and internal policies
• Act as a primary contact for compliance issues, audits, and inspections related to GCP and pharmacovigilance
• Monitor quality-related activities and ensure the integrity of data generated for regulatory submissions

Required Qualifications

• Bachelor's degree in a life science; advanced degree preferred
• At least 10 years of pharmaceutical industry experience, with 8 years in compliance and process management
• A minimum of 5 years management experience of a global team
• Excellent knowledge of GCPs, ICH guidelines, and FDA regulations
• Experience with regulatory authority inspections