Director of Sterile Operations

Job Summary

A company is looking for a Director, Sterile Operations to lead its sterile compounding operation.

Key Responsibilities

• Oversee daily operations in compounding labs, ensuring compliance with production schedules and quality standards
• Foster a culture of safety and compliance with FDA, OSHA, USP 797/800, and cGMP standards
• Manage a cross-functional team and collaborate with various departments to align operational execution with business goals

Required Qualifications

• Bachelor's degree or equivalent professional experience
• 8-10 years of experience in pharmaceutical manufacturing or related operational environments
• Minimum 2 years in a leadership role in sterile compounding or regulated manufacturing
• Demonstrated experience managing complex technical teams and production environments
• Familiarity with lean manufacturing principles and working knowledge of USP and cGMP