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Quality Assurance Manager

3 months ago

Hoffman Estates, United States Seven Executive Full time

QA Manager


General Description


  • The Quality Assurance Manager is responsible for providing leadership in development and implementation of an independent quality system to support bioanalytical lab operations
  • Identify areas of regulatory risk and bring these to the attention of lab management and senior management
  • Responsible for developing and executing training for all employees on quality assurance policies, programs, and initiatives and GLP regulatory requirements
  • Ensure that documents are reviewed and processes conducted and carried out are in accordance with company quality policies and procedures and in compliance with GLP
  • Responsible for writing, reviewing, and approving (where applicable) procedures and quality documentation
  • Conduct review of study data and final reports, in support of regulatory submissions
  • Mentoring Quality Assurance Team and monitor new development of regulations.


Major Duties and Responsibilities


  • Serve as a source of QA advice and guidance to personnel, answer questions regarding QA, procedures and training. Provide a source of advice on GLP requirements.
  • Lead an effective QA team to ensure lab operations are in compliance with GLP requirements.
  • Conduct review and sign off study plans and schedule inspections.
  • Conduct final report reviews and data audits in order to assure that the report is an accurate reflection of the methods used and raw data generated during the study and that the data are compliant. Report any review findings to relevant personnel.
  • Conduct and reporting of quality system audits (internal and vendor).
  • Create, review, control, and/or approve documents required for GLP compliance.
  • Assist management with awareness of compliance issues and appraise management of audit findings, initiating discussions with appropriate personnel as necessary.
  • Assist with preparation, conduct and response to customer and regulatory agency requests and inspections.
  • Responsible for Quality aspects of Sponsor visits/audits and preparation/ issue of report of such visits/audits ensuring completion of any actions.
  • Review site quality policies and procedures and ensure consistency of content of standards with GLP requirements. Present recommendations and changes to management.
  • Management of controlled document system.
  • Provide training in GLP for Bioanalytical department and support departments (where applicable).
  • Maintenance of the final report audit schedule.
  • Sign off Training records for QAU personnel.
  • Coordinate Global Quality standards and practices.
  • Assumes other activities and responsibilities as assigned.


Skills/Knowledge


  • Good understanding of FDA regulations relating to GLP; Sound understanding of quality systems pertaining to contract research supporting Pharmaceutical industry and good documentation practices within a CRO, life science, and pharmaceutical industry.
  • Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems.
  • Ability to handle confidential information with organizational skills for filing and file maintenance.
  • Ability to prioritize and complete work in a timely fashion and demonstrate attention to detail.
  • Be pro-active and demonstrate initiative.
  • Good team player and experience of dealing with complex tasks.
  • Demonstrated effective oral and written communication skills and excellent interpersonal skills; ability to deal with people at all levels.
  • Time-management skills are required, as well as the ability to handle multiple projects.

Work Experience Requirements


3+ years working in a GLP environment with 2+ years in a quality assurance or related role


Education Requirements


Bachelor’s Degree; M.S. degree preferred with industry (pharmaceutical or bio lab) experience and/or equivalent