Director of Microbiology

Job Summary

Leading the global microbiology organization, the full-time remote Director of Microbiology will establish and execute microbiology and sterility assurance strategies, oversee contamination control programs, and ensure compliance with regulatory standards across manufacturing sites.

Key Responsibilities

• Establish and execute the enterprise microbiology and sterility assurance strategy aligned with corporate objectives
• Provide strategic oversight of contamination control strategies and microbiology laboratory operations
• Ensure compliance with global regulatory requirements and lead investigations of microbiological events

Required Qualifications

• Bachelor's degree with 14+ years of experience or advanced degree with 12+ years in Microbiology or related field
• Minimum of 12+ years in pharmaceutical microbiology, sterility assurance, or contamination control
• Extensive experience with global sterile manufacturing operations and regulatory compliance
• Demonstrated expertise in FDA, EMA, and other global GMP regulations
• Proven success in leading regulatory inspections and interactions with health authorities