Senior Director, GMP Quality Assurance

📋 Description

• Lead pharmaceutical quality systems: Develop, implement, govern, and continuously improve the
• Oversee external manufacturing and testing: Provide independent Quality oversight of manufacturing
• Manage product disposition and release: Serve as the final Quality authority for batch disposition
• Review and approve quality documentation: Provide timely, risk-based review of batch records
• Support product and process lifecycle activities: Oversee process and analytical changes
• Manage external partner quality: Establish risk-based qualification, auditing, monitoring, and

🎯 Requirements

• Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry
• At least 15 years of progressively responsible Quality experience in the pharmaceutical or
• Demonstrated experience leading Quality within a fully or substantially outsourced environment
• Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality
• Strong understanding of applicable GMP and Good Distribution Practice (GDP) requirements, including
• Experience interacting directly with regulatory authorities and successfully leading inspections

🎁 Benefits

• Annual base salary: $250,000–$320,000, depending on experience, qualifications, geographic
• Performance-based compensation: A discretionary annual bonus may be available based on individual
• Remote work: Fully remote position within the United States.
• Senior leadership opportunity: The chance to shape Quality strategy, lead a high-performing
• Strategic impact: The opportunity to strengthen global compliance, oversee external manufacturing