ID Biomedical is an integrated biotechnology company dedicated to the development of innovative
vaccine products. It operates in research, development, manufacturing, sales and marketing from
its facilities in Canada and in the United States. ID Biomedical is dedicated to becoming a
worldwide premier vaccine company with significant marketed products and an extensive pipeline
in both clinical and preclinical development.
The Manager, Quality Assurance is the key point of contact for Quality issues affecting
disposition of clinical trial materials during the drug development process.
* Provide oversight to ensure clinical materials are manufactured to phase appropriate GMP
standards, including review and approval of specific procedures and master batch records,
approval of specifications and critical process parameters, discrepancy investigations, and
* Support inventory requirements by ensuring that staff members adhere to standard lead times
for the completion of all lot disposition activities
* Perform review of discrepancies, investigations, QC assay variances, and anomalous results
associated with batch records; demonstrating independent judgment in making decisions for
clinical products based on knowledge of regulatory requirements and industry standards
* Manage corrective actions/preventive actions (CAPA), Change Control Systems and Document
Skills, knowledge and abilities required:
• Experience to perform Quality Assurance activities for the clinical manufacturing of
bio-pharmaceutical products in a GLP/cGMP environment.
• Thorough knowledge of cGMP's, and regulations applicable to U.S. and international
• Ability to manager supervisors and staff personnel, including coaching, counseling, hiring,
disciplining, and resource allocation.
• Experience in the assessment of technical data.
• Excellent verbal and technical written communication skills, interpersonal skills, and
Company: ID Biomedical