Senior Quality Control Manager

3 hours ago

Exton, Pennsylvania, United States Joulé Full time
Job Title:
Associate Director Quality Control


As a key member of our Quality Control team, you will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists. Your primary focus will be on ensuring that day-to-day scheduling of activities is appropriately resourced and that the Environmental Monitoring Program is maintained and updated regularly. This includes monthly trend analysis, yearly alert and action level evaluation, equipment upkeep, logbook review, and order status management. You will also be responsible for managing laboratory equipment upkeep, calibration, and preventive maintenance, as well as ensuring proper documentation in logbooks and electronic management systems. Additionally, you will be responsible for ensuring all method qualification and validation is current, keeping apprised of compendial changes, and ensuring compliance with compendia for all test procedures. You will also manage external vendors providing lab services and materials, maintain appropriate inventory of materials, and ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug Product. You will participate in the establishment of phase-appropriate specifications, ensure data integrity is maintained for all applications, programs, and executed work, and generate protocols, technical reports, and other documentation as needed. You will also author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, root cause analyses, and risk assessment as needed. Furthermore, you will raise critical quality issues to upper management, perform internal audits to ensure compliance with cGMP's, write and revise Quality Systems SOPs and other documentation as necessary to maintain compliance, and support audit of external parties and regulatory inspections. You will also ensure full compliance with applicable health and safety regulations (such as OSHA) and will be willing to engage with a high energy team in pursuit of organizational goals and strategies. Requirements:
Minimum Bachelor of Science degree in a relevant scientific discipline Minimum 10 years of Quality Control experience in the biologics industry, with a minimum of 3 years management experience in Quality Control or Quality Assurance Excellent knowledge of cGMP guidelines, USP/NF, 21 CFR Parts 210 and 211, 21 CFR Part 11, and other regulatory standards Technical writing experience in a similar role in the biologics or pharmaceutical industry Experience in aseptic processing and/or mammalian cell culture production Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills Ability to prioritize and successfully execute multiple tasks simultaneously Ability to work with a high degree of accuracy and detail Positive work attitude that supports teamwork and continuous improvement

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