Sr. Manager, QC Sterility Assurance

ReviveRX; Town of Texas (WI); On-site; USD 99,000 - 136,000; Full time

Job summary

An established industry player is seeking a Sr. Manager for QC Sterility Assurance. This pivotal role involves overseeing sterility assurance and Quality Control programs, ensuring compliance with FDA and USP regulations. You will lead a team of microbiologists, manage contamination control measures, and drive continuous improvement initiatives. Your expertise will be essential in maintaining aseptic control and executing environmental monitoring. Join a forward-thinking company committed to innovation and excellence in the pharmaceutical manufacturing sector, where your contributions will significantly impact product quality and safety.

Qualifications

• 7-10 years in sterility assurance or microbiology in a sterile environment.
• 5 years of managerial experience leading teams in QC.

Responsibilities

• Oversee sterility assurance strategies and ensure regulatory compliance.
• Lead investigations for sterility-related non-conformances.

Skills

Problem-solving

Analytical Skills

Leadership

Communication

Detail-oriented

Education

Bachelor's or Master's in Microbiology

Bachelor's or Master's in Biology

Bachelor's or Master's in Chemistry

Tools

Microbiological Testing Equipment

Environmental Monitoring Systems

Job description

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Job Title: Sr. Manager, QC Sterility Assurance

Department: Quality

Reports To: Sr. Director of Quality

Job Summary

The Sr. Manager, QC Sterility Assurance is responsible for overseeing sterility assurance and Quality Control programs, ensuring compliance with FDA, USP, and other regulatory requirements. This role leads a team of microbiologists and quality professionals to maintain aseptic control, execute environmental monitoring, and drive continuous improvement initiatives in sterility assurance and Quality Control within sterile manufacturing environments.

Key Responsibilities

Sterility Assurance & Microbiological Oversight:

• Lead sterility assurance strategies to ensure compliance with regulatory requirements (FDA, USP, and State Board of Pharmacy guidelines).
• Oversee environmental monitoring programs, media fills, aseptic process validations and continuous quality assurance and improvement plans.
• Manage contamination control measures, including risk assessments, deviation investigations, and CAPAs.
• Ensure robust microbial identification and trending analysis to mitigate contamination risks and make data presentable for site leader visibility.
• Lab qualifications and 3rd Party Management for potency, endotoxin, sterility and stability studies.
  
  

Regulatory Compliance & Audit Support

• Serve as a subject matter expert (SME) for Quality control and sterility assurance in regulatory inspections and audits.
• Lead investigations for sterility-related non-conformances and environmental excursions.
• Ensure proper documentation and reporting of all sterility assurance-related activities.
• Develop, revise, and enforce sterility assurance policies and standard operating procedures (SOPs).
  
  

Leadership & Training

• Manage and mentor a team of microbiologists and QC professionals.
• Provide sterility assurance training for production, QC, and other departments.
• Drive continuous improvement initiatives for aseptic practices and contamination control.
  
  

Process Improvement & Cross-Functional Collaboration

• Collaborate with Compounding, Operations, and Quality Assurance teams to optimize aseptic processes.
• Implement industry best practices and emerging sterility assurance technologies.
• Support cleanroom qualifications, and aseptic process validations.
  
  

Perform other duties as assigned to support departmental and organizational objectives.

Qualifications

• Education: bachelor’s or master’s degree in microbiology, Biology, Chemistry or a related field.
• Experience: Minimum 7-10 years in sterility assurance, microbiology, or QC in a sterile pharmaceutical or biotech environment (cGMP).
• Leadership: At least 5 years of experience in a managerial or higher role.
  
  

Technical Expertise

Strong knowledge of aseptic processing, sterility assurance, and environmental monitoring.

Hands-on experience with cleanroom classifications, contamination control, and microbiological testing.

Familiarity with regulatory guidelines (USP , , , etc.).

Experience leading sterility investigations, CAPAs, and regulatory audits.

Experience in writing, reviewing, and approving protocols and/or reports.

Skills

• Excellent problem-solving and analytical skills.
• Strong leadership, communication, and team-building abilities.
• Detail-oriented with a high level of documentation accuracy.
  
  

Preferred Qualifications

• MBA or advanced degree in a related field.
• Experience with new cleanroom setups and environmental monitoring program implementation.
• Previous experience in regulatory audits and corresponding updates (as required) as SME the for Quality Control and sterility assurance.
  
  

Work Environment

• Must be able to work in and around cleanroom environments.
• Some travel may be required for audits and/or vendor qualifications.
  
  

PI267607113

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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