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
