Senior Director of Quality Compliance

Job Summary

To shape and lead the quality and compliance strategy, the full-time Senior Director of Quality Compliance will define and execute the global compliance strategy for clinical development programs, ensuring adherence to regulatory standards while fostering a culture of quality in a hybrid work environment based in South San Francisco.

Key responsibilities

• Lead the Quality Management System to ensure compliance with cGMP requirements and global regulatory standards
• Collaborate with cross-functional teams to promote a strong culture of quality and manage internal inspection readiness activities
• Oversee compliance risk management assessments and initiatives to mature quality systems in preparation for product commercialization

Required qualifications

• B.S. in Biological Sciences, Chemistry, or Engineering; advanced degree preferred
• 10-12 years of experience in the Pharma/Biotech industry, including 5-6 years in management focused on Quality Systems and Compliance
• In-depth knowledge of Quality Management System requirements for pharmaceutical and biotech manufacturing
• Experience leading regulatory inspections with Global Health Authorities, including Pre-license Inspections
• Strong interpersonal skills with the ability to communicate findings effectively to various audiences