Quality Assurance Manager

BRT is seeking a dedicated Quality Assurance Manager to oversee its QA program, host regulatory and sponsor audits, ensure GLP compliance and more.

Requirements:

  • B.A./B.S. or higher
  • Previous experience as a GLP auditor in a regulated facility
  • >5 years of industry (pharmaceutical or CRO) experience, with knowledge and experience in a GLP environment
  • Proven ability to manage multiple projects/tasks at one time and oversee compliance and quality systems
  • Good time-management skills and demonstrated ability to provide deliverables within specified timelines
  • Excellent written and oral communication skills

Responsibilities:

  • Management of QA program and hosting of regulatory and sponsor audits
  • Working with BRT management and staff regarding compliance, training, and maintenance of QA-related documents
  • Development and implementation of QA procedures to ensure GLP compliance
  • Training of QA staff
  • Monitoring of facilities, personnel, methods, practices, records, and controls for GLP compliance
  • Making recommendations for continuous improvement and correcting deficiencies
  • Ensuring proper authorization and documentation for deviations for approved protocols or SOPs
  • Review and tracking of deviations and corrective actions
  • Conducting and documenting periodic internal audits and providing status reports
  • Auditing protocols, study phases, and final reports
  • Providing QA statements for GLP study reports
  • Maintaining a master schedule and other QA-related documents

Additional qualifications that are valuable to the position but not a prerequisite to employment include:

  • QA supervisory or management experience is desirable
  • Experience with rodent studies and bioanalytical assays is optional but desirable
  • Desire to work in a responsive and fast-paced environment
  • Detail-oriented individual with a dedication to quality
  • Motivated self-starter with a strong work ethic
  • Good communicator able to work with internal staff and external clients

Apply

To apply to this position, please complete the following form and attach your resumé, cover letter and a list of three references.

Disclaimer: Job responsibilities listed above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.