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Director QC Operations - Microbiology

United States, Bedford · Job Posted January 02, 2026
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Job Description

The Director of QC Operations - Microbiology provides strategic leadership and scientific oversight for all microbiology quality control operations. This role manages staff, programs, and systems supporting environmental monitoring of classified spaces, clean utility control, and microbiological testing of raw materials, intermediates, and finished products. The Director ensures effective training in aseptic and microbiological techniques, drives continuous improvement in contamination control practices, and strengthens QC microbiology capabilities across the organization. Leveraging technical expertise and sound judgment, the Director ensures a robust state of control and supports the reliable delivery of high-quality products.

Job Responsibility

  • Provide strategic direction, leadership, and oversight for all QC Microbiology operations across NH sites
  • Develop and implement long-term QC microbiology strategies, technologies, and process improvements
  • Oversee and continuously improve core QC Microbiology programs including Environmental Monitoring (EM), Utility Monitoring, Product Microbiology Testing, and Contamination Control initiatives
  • Ensure microbiology programs, methods, and systems remain compliant, scientifically sound, and optimized
  • Provide review and approval of microbiology data, technical assessments, and quality documents
  • Lead, mentor, and develop QC Microbiology managers and staff
  • Provide executive oversight and guidance for microbiology-related deviations, investigations, CAPAs, and quarterly/trend reports
  • Drive proactive contamination control strategies and risk mitigation plans
  • Ensure all microbiology operations adhere to cGMP, global regulatory expectations, corporate policies, and quality standards
  • Partner closely with Operations, Facilities, Validation, Quality Assurance, and other key functions
  • Strengthen relationships and maintain effective communication channels across sites, organizations, and external partners
  • Evaluate and introduce new technologies, methods, and systems that improve efficiency, compliance, and contamination control robustness

Requirements

  • 10+ years of relevant working experience in QC Microbiology
  • 5-8 years of management/leadership responsibilities
  • BS in Microbiology, Biology or related life sciences field
  • Excellent communication skills, both written and verbal
  • Strong attention to detail and cross functional team experience
  • Proven strong leadership skills with ability to motivate, inspire and build a high performing team
  • In-depth knowledge of US, EU and other international regulations and guideline associated with environmental monitoring programs

Nice to have

  • Previous experience in aseptic manufacturing
  • Advanced level degree
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