Quality Assurance Manager

3 weeks ago

Chicago, United States Plexus Partners Full time

Quality Assurance Manager – GLP - Chicago


Plexus are partnered with a fast-growing, internationally recognised CRO with a fantastic reputation, renowned for their quality, lab staff and innovation.


This is a rare position to manage and build a Quality Assurance team within their purpose built, Chicago-based facility, with best in-class technology


GENERAL DESCRIPTION


The Quality Assurance (QA) Manager is responsible for leading the development and implementation of an independent quality system to support laboratory operations. This role involves identifying areas of regulatory risk and bringing them to the attention of lab and senior management. The QA Manager will develop and execute training on quality assurance policies, programs, initiatives, and Good Laboratory Practices (GLP) regulatory requirements. Additionally, they will ensure that all documents and processes align with company quality policies, procedures, and GLP compliance. The position involves writing, reviewing, and approving procedures and quality documentation, as well as reviewing study data and final reports for regulatory submissions. Mentoring the Quality Assurance team and monitoring new regulatory developments are also key responsibilities. The QA Manager will coordinate global quality standards and practices.


RESPONSIBILITIES


  • Serve as a QA advisor, offering guidance on procedures and training, and provide advice on GLP requirements.
  • Lead the QA team to ensure laboratory operations comply with GLP regulations.
  • Review and approve study plans and schedule inspections.
  • Review final reports and conduct data audits to ensure accuracy and compliance with methods and raw data.
  • Conduct and report on internal and vendor quality system audits.
  • Create, review, control, and/or approve documents required for GLP compliance.
  • Assist management with compliance awareness and report audit findings, facilitating necessary discussions with relevant personnel.
  • Assist with preparation, conduct, and response to customer and regulatory agency requests and inspections.
  • Manage the quality aspects of sponsor visits/audits and ensure timely completion of any required actions.
  • Review site quality policies and procedures, ensuring consistency with GLP standards, and present recommendations to management.
  • Manage the controlled document system.
  • Provide GLP training as needed.
  • Maintain the final report audit schedule.
  • Approve training records for QA personnel.
  • Coordinate global quality standards and practices.
  • Perform additional tasks and responsibilities as assigned.



SKILLS/KNOWLEDGE


  • Strong understanding of FDA regulations related to GLP.
  • In-depth knowledge of quality systems in contract research, pharmaceutical industries, and good documentation practices.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and capable of quickly learning new systems.
  • Excellent organizational skills and ability to handle confidential information effectively.
  • Strong attention to detail, ability to prioritize tasks, and complete work in a timely manner.
  • Demonstrates initiative and proactivity.
  • Effective communication skills, both oral and written, and strong interpersonal skills.
  • Capable of managing time effectively and handling multiple projects.


EDUCATION REQUIREMENTS


  • Bachelor’s degree required; M.S. degree preferred with industry experience in pharmaceuticals or bio-labs, or equivalent experience.

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