QA MANAGER Variation Biotechnologies Inc.
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.
||Cambridge, MA |