Manager, Quality Assurance - Microbiology and Sterility Assurance

This individual will need to be located in the East or Midwest region of the United States.

About the role

Quality Assurance develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. This role provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures to ensure that all products and services are properly reviewed for quality and documented.

The Microbiology & Sterility Assurance Manager is responsible for overseeing the microbiology and sterility assurance programs supporting the manufacturing of PET radiopharmaceuticals. This role ensures compliance with applicable FDA regulations, USP requirements, cGMP standards, and internal quality requirements related to aseptic processing, environmental monitoring, sterility assurance, contamination control, and microbiological testing. The position provides technical leadership for sterility assurance activities across manufacturing operations and supports continuous improvement initiatives to maintain a state of control.

Responsibilities

• Sterility Assurance Program Leadership: Lead and maintain the site's Sterility Assurance Program to ensure compliance with cGMP regulations, USP standards, and internal quality requirements.
• Environmental Monitoring Program Management: Manage and continuously improve the Environmental Monitoring Program, including data review, trend analysis, investigations, and CAPA implementation for Environmental Monitoring results. Establish, maintain, and periodically assess environmental monitoring alert and action limits to ensure effective process control.
• Microbiological Testing Programs: Manage and direct all microbiological testing programs, including environmental monitoring, growth promotion, media qualification, and microorganism identification. Oversee routine testing and validate new product methods for sterility, bacterial endotoxin, and bioburden.
• Media Fill Studies and Aseptic Process Qualifications: Lead the planning, execution, and evaluation of media fill studies, process simulations, and aseptic process qualifications, including assessing process changes and interventions.
• Investigations Support: Support microbiology and sterility assurance investigations related to deviations, contamination events, sterility failures, CAPAs, change controls, and risk assessments.
• Documentation and Quality Systems: Develop, review, approve, and maintain microbiology and sterility assurance procedures, protocols, reports, specifications, and quality system documentation.
• Subject Matter Expertise: Serve as the microbiology and sterility assurance Subject Matter Expert (SME) for Quality, Compliance, Product Development, and Manufacturing. Provide technical leadership and guidance while supporting regulatory inspections, customer audits, and internal corporate assessments.
• Regulatory Compliance: Monitor and interpret evolving regulatory requirements and industry guidance to ensure ongoing compliance and inspection readiness.
• Technical Leadership and Training: Provide technical leadership, coaching, and training to Quality, Manufacturing, and Operations personnel on aseptic processing, contamination control, and microbiological best practices.
• Cross-functional Collaboration: Collaborate with Manufacturing, Engineering, Training, Validation, Regulatory Affairs, and Quality teams to support product quality, process improvements, and contamination control initiatives.
• Data Analysis and Continuous Improvement: Analyze microbiological, environmental monitoring, and process performance data to identify risks, drive continuous improvement, and enhance overall sterility assurance across the facility.

Requirements

• Bachelor’s degree in microbiology, Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific field, preferred.
• 8+ years of experience in Quality, QC microbiology, contamination control, sterility assurance, or a related GMP function within the biotechnology or pharmaceutical industry, preferred.
• At least 1 year of experience leading microbiology laboratories, environmental monitoring programs, or contamination control technical workstreams, preferred.
• Ability to work effectively with different PET site teams across time zones while adapting approaches based on technical complexity, regulatory considerations, and stakeholder needs.
• Effective English written and verbal communication skills; additional language capability is a plus.
• Ability to travel domestically and internationally up to 50% of the time.

Preferred Qualifications

• Strong technical knowledge of microbiology and contamination control practices, including environmental monitoring, bioburden, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, and facilities.
• Experience supporting GMP investigations, deviations, CAPAs, change controls, risk assessments, audits, inspection readiness, or regulatory inspection activities.
• Experience in sterile manufacturing, aseptic processing, drug substance manufacturing, or QC microbiology laboratory operations.
• Experience contributing to multi-site standards, procedures, technical guidance, training materials, quality intelligence, or quality system improvements.
• Ability to interpret and apply GMP, GXP, regulatory, compendial, and industry expectations to microbiology, manufacturing, Quality Control, and contamination control processes.

Level Expectations

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Participates in the development of policies and procedures to achieve specific goals.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope, with projects potentially having significant and long-term impact.
• Provides solutions which may set precedent.
• Independently determines method for completion of new projects and receives guidance on overall project objectives.
• Acts as a mentor to less experienced colleagues.

Pay

Anticipated salary range: $105,100 - $150,100. Bonus eligible.

Benefits

• Medical, dental, and vision coverage.
• Paid time off plan.
• Health savings account (HSA).
• 401k savings plan.
• Access to wages before pay day with myFlexPay.
• Flexible spending accounts (FSAs).
• Short- and long-term disability coverage.
• Work-Life resources.
• Paid parental leave.
• Healthy lifestyle programs.