Manager, Quality Assurance - Microbiology and Sterility Assurance

Job description

This individual will need to be located in the East or Midwest region of the United States What Quality Assurance contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. Job Summary 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: Leading and maintaining the site's Sterility Assurance Program to ensure compliance with cGMP regulations, USP standards, and internal quality requirements Environmental Monitoring Program Management: Managing and continuously improving the Environmental Monitoring Program, which involves data review, trend analysis, investigations, and CAPA implementation for Environmental Monitoring results including establishing, maintaining, and periodically assessing 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. This also encompasses overseeing routine testing and validating new product methods for sterility, bacterial endotoxin, and bioburden Media Fill Studies and Aseptic Process Qualifications: Leading 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 : Developing, reviewing, approving, and maintaining 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, providing technical leadership and guidance while supporting regulatory inspections, customer audits, and internal corporate assessments Regulatory Compliance: Monitoring and interpreting evolving regulatory requirements and industry guidance to ensure ongoing compliance and inspection readiness Technical Leadership and Training: Providing technical leadership, coaching, and training to Quality, Manufacturing, and Operations personnel on aseptic processing, contamination control, and microbiological best practices Cross-functional Collaboration: Collaborating cross-functionally 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: Analyzing microbiological, environmental monitoring, and process performance data to identify risks, drive continuous improvement, and enhance overall sterility assurance across the facility Qualifications Bachelor’s degree in microbiology, Biology, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific academic background, 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 Additional 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 What is expected of you and others at this level 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 Projects may have significant and long-term impact Provides solutions which may set precedent Independently determines method for completion of new projects Receives guidance on overall project objectives Acts as a mentor to less experienced colleagues Anticipated salary range: $105,100 - $150,100 Bonus eligible: Yes Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being. 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 Application window anticipated to close: 09/22/2026 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity. Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law. To read and review this privacy notice click here