Job Description SummaryAre you a driven validation leader ready to shape quality standards and drive engineering excellence across complex operations? Join STEMCELL Technologies as the Manager, Validation Engineering, where you will lead a dynamic team, oversee robust Quality Assurance Validation strategies, and ensure seamless regulatory compliance at Canada’s largest biotechnology company!
In this key leadership role, you will provide critical cross-functional guidance, align validation practices with industry standards, and mentor engineering professionals. You will collaborate closely with cross-departmental teams to champion innovative validation frameworks and uphold the highest quality and safety benchmarks across our facilities.
If you’re a strategic thinker and proactive leader who excels in high-stakes compliance and thrives in a collaborative, fast-paced environment, we want to hear from you!
Job DescriptionDuties and Responsibilities
- Leads, directs and reviews the work of quality validation engineers, establishes annual goals and performance standards, identifies training needs, and recommends adjustments to training materials
- Oversees and maintains Quality Management Systems (QMS), operational standards, and procedural controls necessary for the Commissioning, Qualification and Validation (CQV)
- Directs continuous improvement within quality assurance (QA) processes by monitoring and evaluating metrics and key performance indicators (KPIs) to analyze effectiveness, recognize trends, and implement operational enhancements
- Manages technical guidance and resource allocation across project teams engaged in multidisciplinary product development, lifecycle management, and design control
- Collaborates cross-functionally to integrate quality knowledge and compliance protocols into business operations and effectively resolves complex quality issues
Knowledge and Qualifications
- Bachelor’s degree in Sciences or Engineering with a minimum of 8 years of progressive experience in quality assurance in a regulated industry
- 1 to 3 years of direct experience leading, supervising, or mentoring teams
- Specialized and extensive knowledge of Quality System regulatory requirements (ISO 13485, ISO 9001, and FDA 21 CFR regulations)
- Demonstrated practical experience implementing, managing, and auditing QMS, with experience in Computer System Validation is an asset
- Proven ability to balance regulatory compliance with business and operational requirements
#Nonbench #LI-Onsite #LI-ML1
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.
STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.
The annual salary for this job ranges from:
$116,700.00 - $175,100.00
STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.
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