Manager, Quality Assurance, Commissioning, Qualification and Validation
Job Description SummaryAs the Manager of Validation, you'll be at the forefront of advancing our compliance strategy. This role is not just about managing, it's about nurturing the next generation of Validation Engineers, providing strategic guidance, and leveraging your industry expertise in key facilities, equipment, and manufacturing projects. This role involves solving technical challenges, requiring in-depth critical thinking skills. Your decisions directly influence the department and organization, contributing to STEMCELL's commitment to pushing the boundaries of scientific innovation. If you are a seasoned professional in the realm of Validation and Compliance, join a team that embraces and pioneers cutting-edge technologies and practices, ensuring you stay at the forefront of your field.
Duties and Responsibilities
Lead, develop, and implement a business-appropriate compliance philosophy and standard approach to validation
Provide quality oversight for the qualification and validation activities for equipment, utilities, and facilities supporting cGMP manufacturing facilities and Quality Control Labs
Ensure the framework and methodology across all qualification and validation activities comply with applicable regulations and standards
Building strong relationships, influencing and mentoring cross-functional leadership and team members in technical performance and validation requirements that meet the business needs
Lead project teams and provide direction throughout the project delivery life cycle, supporting internal and external stakeholders
Knowledge and Qualifications
Requires a Bachelor’s Degree with at least 8 years of GxP experience in a pharmaceutical, biotechnology, or medical device industry
Experience with cGMP commissioning, qualification, and validation of biotech equipment and facilities is required including overall validation lifecycle experience
Strong knowledge of cGMP’s 21 CFR Part 210 and 211
Ability to think strategically and to proactively identify issues
Flexibility to travel to our greater Vancouver locations to provide on-site support and guidance as required
#Nonbench #LI-Onsite #LI-ML1
STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services. Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 2300 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.
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.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. We know that scientific progress and innovation occur when diverse, creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.
The annual base salary for this job ranges from:$95,200.00 - $142,800.00
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.
NOTE: STEMCELL’s vaccination policy requires that all candidates for this role be fully vaccinated against COVID-19 (including boosters), as currently recommended or required by local health authorities and public health orders, unless an exemption from this policy is approved through our accommodation request process.
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