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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
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