System One Holdings, LLC
Quality Control Manager
System One Holdings, LLC, Exton, Pennsylvania, United States, 19341
Job Title:
Quality Control ManagerLocation : Exton, PASalary Range:
120-160kSchedule : Monday - Friday Day Hours
Our client is a cell & gene therapy company that is rapidly growing. They arelooking for a dynamic
Quality Control Manager
to join the team in Exton, PA and play a key role in shaping the future of the QC department. This is more than just a management role-it's an opportunity to build and develop a talented team while driving positive culture change. You'll oversee vital QC operations, including our Environmental Monitoring Program, equipment maintenance, and method validation, all while ensuring top-tier regulatory compliance. If you're passionate about group building, fostering a collaborative environment, and making an impact, this is the perfect role for you!
Responsibilities:Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourcedMaintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order statusManage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systemsEnsure all method qualification and validation is current.Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays (additional analytical platforms maybe implemented as per business needs)Keep apprised of compendial changes and ensure compliance with compendia for all test proceduresManage external vendors providing lab services and materialsMaintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budgetEnsure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug ProductParticipate in the establishment of phase-appropriate specificationsEnsure data integrity is maintained for all applications, programs, and executed workGeneration of protocols,technical reports, and other documentation as neededAuthor and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations,root cause analyses, and risk assessment as neededRaise critical quality issues to upper managementPerform internal audits to ensure compliance with cGMP'sWrite and revise Quality Systems SOPs and other documentation as necessary to maintain complianceTraining and development of employeesSupport audit of external parties and regulatory inspectionsEnsure full compliance with applicable health and safety regulations (such as OSHA)Willingness to engage with a high energy team in pursuit of organizational goals and strategiesRequirements:
Minimum Bachelor of Science degree in a relevant scientific disciplineMinimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality AssuranceExcellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standardsTechnical writing experience in a similar role in the biologics or pharmaceutical industryExperience in aseptic processing and/or mammalian cell culture productionFlexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skillsAbility to prioritize and successfully execute multiple tasks simultaneouslyAbility to work with a high degree of accuracy and detailPositive work attitude that supports teamwork and continuous improvement
#M3
Quality Control ManagerLocation : Exton, PASalary Range:
120-160kSchedule : Monday - Friday Day Hours
Our client is a cell & gene therapy company that is rapidly growing. They arelooking for a dynamic
Quality Control Manager
to join the team in Exton, PA and play a key role in shaping the future of the QC department. This is more than just a management role-it's an opportunity to build and develop a talented team while driving positive culture change. You'll oversee vital QC operations, including our Environmental Monitoring Program, equipment maintenance, and method validation, all while ensuring top-tier regulatory compliance. If you're passionate about group building, fostering a collaborative environment, and making an impact, this is the perfect role for you!
Responsibilities:Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourcedMaintenance of the viable and non-viable Environmental Monitoring Program, including monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order statusManage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systemsEnsure all method qualification and validation is current.Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays (additional analytical platforms maybe implemented as per business needs)Keep apprised of compendial changes and ensure compliance with compendia for all test proceduresManage external vendors providing lab services and materialsMaintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budgetEnsure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug ProductParticipate in the establishment of phase-appropriate specificationsEnsure data integrity is maintained for all applications, programs, and executed workGeneration of protocols,technical reports, and other documentation as neededAuthor and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations,root cause analyses, and risk assessment as neededRaise critical quality issues to upper managementPerform internal audits to ensure compliance with cGMP'sWrite and revise Quality Systems SOPs and other documentation as necessary to maintain complianceTraining and development of employeesSupport audit of external parties and regulatory inspectionsEnsure full compliance with applicable health and safety regulations (such as OSHA)Willingness to engage with a high energy team in pursuit of organizational goals and strategiesRequirements:
Minimum Bachelor of Science degree in a relevant scientific disciplineMinimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality AssuranceExcellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standardsTechnical writing experience in a similar role in the biologics or pharmaceutical industryExperience in aseptic processing and/or mammalian cell culture productionFlexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skillsAbility to prioritize and successfully execute multiple tasks simultaneouslyAbility to work with a high degree of accuracy and detailPositive work attitude that supports teamwork and continuous improvement
#M3