VBI is seeking a QA Manager with industry experience in QA/QC and GxP to join our dynamic team to assist in development of pre-clinical and early clinical vaccine candidates. This position will be based at VBI’s Research Facilities in Ottawa, Ontario, Canada, and will require occasional international travel.
- Ensure quality oversight and GxP compliance of third party vendors (CMO, analytical and other critical vendors) as VBI’s primary QA interface
- Be responsible for the development, maintenance, review and approval of external audit reports
- Implementation, maintenance and continuous improvement of all aspects of the internal quality management system
- Provide training for Good Documentation Practices and Good Laboratory Practices, as necessary, and assign relevant procedural training in particular for new hires
- Review and organize periodic revision of all general quality SOPs
- Responsible for document management for all VBI documentation (policies, procedures and controlled forms) including document changes requests, notifications of new documents mastered
- Responsible for the maintenance of employee training records and training matrices (assignments)
- Organize Quality meetings (prepare and send agenda, prepare and distribute meeting minutes, follow up on action items)
- Participate in senior management review – documenting minutes and implementation of agreed corrective actions
- Assist Manager of Research Operations, as necessary, in research and quality activity project management
Experience and Qualification
- Bachelor degree in scientific field
- QA/QC experience supporting successful late preclinical and Phase 1 campaigns in biotech or pharmaceutical company setting
- Experience in GxP for vaccines and/or biopharmaceutical products
- Project management experience and interest desirable
- Meticulous, organized and motivated to work independently and in a team-setting as necessary
- Excellent written and verbal communication skills
- Fluent in English
- $60,000-$85,000, commensurate with experience and qualifications.
Please send your resume including a cover letter outlining your qualifications and interest in joining VBI’s team to Misha Nossov at firstname.lastname@example.org, with a subject line including “QA Manager Application”.