Manager, Quality Assurance - Microbiology and Sterility Assurance

** 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_*
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** 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

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** 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

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** 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

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** 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

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** Investigations support:
** Support microbiology and sterility assurance investigations related to deviations, contamination events, sterility failures, CAPAs, change controls, and risk assessments

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** Documentation and Quality Systems** :
Developing, reviewing, approving, and maintaining microbiology and sterility assurance procedures, protocols, reports, specifications, and quality system documentation

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** 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

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** Regulatory Compliance:
** Monitoring and interpreting evolving regulatory requirements and industry guidance to ensure ongoing compliance and inspection readiness

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** 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

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* 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

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** 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 work streams, 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…