Job Description

Job Title: Quality Manager I (Engineering)
Job Location: Toronto, ON M2R 3T4 / Hybrid
Duration: 12 Months Extendable Contract

The job will be hybrid but I would expect the person to be on-site at least 2 days per week.

:
The Analytical Excellence (AE) Department in QC is responsible for ensuring the validated state of QC test methods over their lifecycle. The QC AE Technical Manager is responsible for managing change controls related to test methods, as well as for supporting the maintenance and coordination of activities in the AE laboratory, and to provide support for projects managed by the AE team.

Key Accountabilities:
Change Control Activities:

• Initiate and manage change control requests for AE
• Assist with timely closure of change controls
• Support QC laboratories, where required, for creation and approval of change controls in a timely manner to support closure of deviations, implementation of new/optimized test methods, and removal of existing test methods

Other Activities:

• Coordinate and perform routine maintenance and lab management activities to ensure compliance with cGMP and Quality Systems is maintained in the AE lab
• Manage Quality Documentation for QC AE lab equipment and processes
• Provide support to AE staff for activities related to test method validation and improvement, including creation and coordination of sample requests, creating and managing independent demand requests, preparing sample labels, etc.
• Perform other duties as requested by management team.

Required Education, skills, and experience:

• Bachelor's Degree/Undergraduate Degree in Biology, Life Sciences or related degree. Masters Degree preferred.
• Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment is required
• Ability to work under strict deadlines
• Ability to interface with cross-functional teams
• Detail oriented
• Strong working knowledge of Quality Systems and Regulations
• Experience leading CAPA (Corrective and Preventive Action) activities
• Ability to handle multiple projects concurrently
• Well-developed communication skills, both verbal and written
• Outstanding Technical Skills (including various computer programs and systems)

Years of Experience: Minimum 3 Years

Managers Notes:

• Experience with change controls, CAPAs, investigations, equipment qualification, and equipment maintenance (eg calibration, etc).
• Project management skills and experience working in a lab would also be an asset.