What You’ll Do:

• Manage and develop the Quality Control team, fostering a culture of excellence and continuous improvement
• Be responsible for management of the daily activities of Quality Control functions pertaining to product testing and release
• Oversee stability and viability testing programs for live probiotic products
• Develop and implement quality control protocols and standard operating procedures (SOPs)
• Utilize flow cytometry and other advanced techniques to assess product quality and consistency
• Provide quality oversight for qualification and validation activities including protocol generation, execution, and final report documentation
• Evaluate methods being transferred to QC and design experiments to support validation activities
• Analyze and interpret quality control data, preparing comprehensive reports for management. 
• Serves as the main point of contact for external laboratories for activities related to onboarding, communicating discrepancies, investigations, and standardizing methodology.  
• Ensure compliance with cGMP regulations and industry standards
• Participate in regulatory inspections and internal audits
• Drive process improvements to enhance efficiency and accuracy in quality control operations
• Collaborate with cross-functional teams to address quality issues and implement corrective actions
• Compile and analyze KPIs indicative of production line health and drive improvement actions
• Troubleshoot non-conformances, drive root cause analysis, and implement corrective actions
• Provide training and mentoring to operations teams on food safety and quality related topics

Knowledge Requirements:

• Bachelor’s degree in Microbiology, Biology, or a related field; Master’s degree preferred
• Minimum of 7 years of quality control experience in the pharmaceutical, biotechnology, or probiotic industry, with at least 3 years in a managerial role
• Extensive knowledge of microbiology techniques, with a focus on probiotic organisms
• Proven expertise in flow cytometry and its application in assessing microbial viability
• Strong understanding of cGMP regulations and quality management systems
• Experience with stability testing programs and data analysis
• Proficient in general and non-routine laboratory skills
• Experience in assay qualification and validation
• Knowledge and understanding of US regulations and guidance applicable to Quality Control and method validation
• Strong analytical and problem-solving abilities
• Proficiency in statistical analysis and quality control software
• Excellent written and verbal communication skills
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities
• Experience using structured and data-driven problem-solving techniques
• Established project management skills
• Willingness to work flexible schedules as needed to support production facilities

Salary & Benefits

• $100,000 - $125,000
• Medical, Dental, and Vision
• Commuter Benefits
• Life & STD Insurance
• Company match on 401 (k)
• Flexible Time Off (FTO)
• Equity