Quality Control Manager

3 weeks ago

Exton, Pennsylvania, United States System One Full time

Job Title:
Quality Control Manager

Schedule:
Monday - Friday Day Hours

Our client is a cell & gene therapy company that is rapidly growing. They are looking for a dynamic Quality Control Manager to 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.

Key Responsibilities:

  • Manage a staff of Quality Control analysts and Environmental Monitoring specialists ensuring that day-to-day scheduling of activities is appropriately resourced
  • Maintenance 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 status
  • Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems
  • 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)
  • Manage external vendors providing lab services and materials
  • Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget
  • Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final Drug Product
  • Ensure data integrity is maintained for all applications, programs, and executed work
  • Author and manage QC change controls, test procedure revisions, SOP revisions, laboratory investigations, root cause analyses, and risk assessment as needed
  • Raise critical quality issues to upper management
  • Write and revise Quality Systems SOPs and other documentation as necessary to maintain compliance
  • Training and development of employees
  • Support audit of external parties and regulatory inspections

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
  • Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., We help clients get work done more efficiently and economically, without compromising quality.

System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

  • Senior Quality Control Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Summary: We are seeking a highly experienced Senior Quality Control Manager to lead our Quality Control team. The ideal candidate will have a strong background in Quality Control, with a minimum of 10 years of experience in the biologics industry. The successful candidate will be responsible for managing a staff of Quality Control analysts and...

  • Senior Quality Control Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Associate Director Quality ControlAs 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...

  • Quality Control Laboratory Manager

    3 weeks ago

    Exton, Pennsylvania, United States Beacon Hill Full time

    Job Summary:We are seeking a highly skilled Quality Control Laboratory Manager to join our team at Beacon Hill. The successful candidate will be responsible for directing the Quality Control functions and providing direct support of all Quality Control processes, test procedures, and procedure validation activities.Key Responsibilities:Manage a staff of...

  • Senior Quality Control Laboratory Manager

    4 weeks ago

    Exton, Pennsylvania, United States Beacon Hill Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Quality Control Laboratory Manager to join our team at Beacon Hill. The successful candidate will be responsible for directing the Quality Control functions and providing direct support of all Quality Control processes, test procedures, and procedure validation activities.Key...

  • Quality Control Specialist

    3 weeks ago

    Exton, Pennsylvania, United States Actalent Full time

    Job Title:Quality Control SpecialistActalent is seeking a Quality Control Specialist to join our team in Exton, Pennsylvania. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products by assisting in the operation and development of QC functions. You will maintain accurate and timely inspection of current products...

  • Quality Control Specialist

    3 weeks ago

    Exton, Pennsylvania, United States Actalent Full time

    Job Title: QC TechnicianAt Actalent, we are seeking a highly skilled QC Technician to join our team in Exton, Pennsylvania. The successful candidate will be responsible for ensuring the quality of our products by assisting in the operation and development of QC functions. This role requires a strong attention to detail and the ability to maintain accurate...

  • Quality Control Specialist

    3 weeks ago

    Exton, Pennsylvania, United States Actalent Full time

    Job Title: QC TechnicianJob DescriptionAt Actalent, we are seeking a highly skilled QC Technician to join our team in Exton, Pennsylvania. As a QC Technician, you will play a critical role in ensuring the quality of our products by assisting in the operation and development of QC functions. Your primary responsibilities will include maintaining accurate and...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Quality Control ManagerAs a Quality Control Manager at Joulé, you will be responsible for leading a team of Quality Control analysts and Environmental Monitoring specialists to ensure the highest standards of quality in our biologics production process. This role requires a strong background in quality control, regulatory compliance, and...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Quality Control ManagerJob Summary: We are seeking a highly experienced Quality Control Manager to join our team at Joulé. The successful candidate will be responsible for managing a staff of Quality Control analysts and Environmental Monitoring specialists, ensuring that day-to-day scheduling of activities is appropriately resourced.Key...

  • Quality Assurance Manager

    3 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: Quality Control ManagerLocation: Exton, PASalary Range: 110-140kSchedule: Monday - Friday Day HoursOur client is a rapidly growing cell & gene therapy company seeking a dynamic Quality Control Manager to join the team in Exton, PA. This is a unique opportunity to build and develop a talented team while driving positive culture...

  • Quality Assurance Manager

    3 weeks ago

    Exton, Pennsylvania, United States System One Full time

    Job Title: Quality Control ManagerLocation: Exton, PASalary Range: kSchedule: Monday - Friday Day HoursSystem One is seeking a Quality Control Manager to join our team in Exton, PA. As a key member of our Quality team, you will play a vital role in shaping the future of our QC department.This is a dynamic management role that offers the opportunity to build...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States System One Holdings, LLC Full time

    Job Title: Quality Control ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities:Lead a team of Quality Control analysts and Environmental Monitoring specialists to ensure day-to-day scheduling of activities is appropriately resourced.Maintain the Environmental Monitoring Program, including monthly trend...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States System One Full time

    Job Title: Quality Assurance ManagerLocation: Exton, PAType: Contract to hireSchedule: Monday - Friday Day HoursResponsibilities: Oversee a team of Quality Control analysts and Environmental Monitoring specialists to ensure effective day-to-day scheduling of activities Maintain the Environmental Monitoring Program, including monthly trend analysis, yearly...

  • Quality Systems Manager

    4 weeks ago

    Exton, Pennsylvania, United States Zenith LifeScience Full time

    Job Title: Quality Systems ManagerLocation: Exton, PADuration: 12 MonthsJob Summary:This role is responsible for maintaining and improving Quality Systems for the Company Americas Region to ensure ongoing compliance with applicable compendia, GMPs, and regulatory guidance. The Quality Systems include quality risk management, documentation, global and local...

  • Contract Quality Systems Manager

    4 weeks ago

    Exton, Pennsylvania, United States Hired by Matrix Full time

    Job Title: Contract Quality Systems ManagerWe are seeking a highly skilled Contract Quality Systems Manager to join our team at Hired by Matrix, Inc. This is a contract position that offers a competitive salary, benefits, and a 401k option with a company match after one year.Job Summary:The Contract Quality Systems Manager will be responsible for maintaining...

  • Contract Quality Systems Manager

    4 weeks ago

    Exton, Pennsylvania, United States LanceSoft Full time

    Job SummaryThis is a challenging role that requires a strong background in quality systems and a proven track record of ensuring compliance with regulatory requirements. The successful candidate will be responsible for maintaining and improving quality systems for the Americas region, ensuring ongoing compliance with applicable compendia, GMPs, and...

  • Quality Control Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: QC Environmental Monitoring SpecialistOur client, a cell and gene therapy company, is seeking a Quality Control Specialist to support environmental monitoring in cleanrooms and ensure product quality. Responsibilities: Conduct environmental monitoring in clean rooms, verify batch records, perform growth promotion testing, and maintain laboratory...

  • Quality Control Specialist

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title: QC Environmental Monitoring SpecialistOur client, a cell and gene therapy company, is seeking a Quality Control Specialist to support aseptic manufacturing and ensure product quality. The ideal candidate will have experience in biologics/pharmaceuticals, particularly in aseptic processing and mammalian cell culture.Responsibilities: Conduct...

  • Quality Assurance Manager

    4 weeks ago

    Exton, Pennsylvania, United States Joulé Full time

    Job Title:Quality Assurance ManagerAt Joulé, we are seeking a highly skilled Quality Assurance Manager to join our team. This role will be responsible for ensuring that our quality systems meet the highest standards of excellence.Responsibilities:Collaborate with cross-functional teams to ensure that quality systems are aligned with business...

  • Director of Quality Assurance

    4 weeks ago

    Exton, Pennsylvania, United States Frontage Laboratories Full time

    Job Title: Director of Quality AssuranceFrontage Laboratories is seeking a highly skilled and experienced Director of Quality Assurance to join our team.Job Summary:The Director of Quality Assurance will play a critical role in the development, maintenance, and continuous improvement of quality management systems to uphold quality standards and...