Director, Quality Assurance
Job Description SummaryJoin STEMCELL Technologies as a Director, Quality Assurance, Quality Lifecycle Management and play a crucial role in ensuring the quality and compliance of our innovative biotechnology products. As a leader in the industry, STEMCELL is committed to providing cutting-edge solutions that advance scientific research and improve patient outcomes. If you have a passion for quality, a deep understanding of regulatory requirements, and a desire to drive continuous improvement, we want to hear from you!
As the Director, Quality Assurance, you will lead and support all aspects of product realization related to quality, overseeing the teams responsible for ensuring the efficient and compliant development and commercialization of STEMCELL’s products. You will collaborate closely with leaders from departments including Research and Development (R&D), Process Development, and Regulatory Affairs, continuously learning from one another and ensuring product realization goals are met.
Duties and Responsibilities
Evaluating and optimizing the New Product Introduction (NPI) process, ensuring relevant partners are educated and informed through clear communications
Conducting strategic assessments of metrics and leading improvement activities to foster a culture of continuous improvement
Promoting a culture of quality and accountability, establishing Key Performance Indicators (KPI) to measure and drive improvement
Growing the regulatory understanding within the Quality Lifecycle Management team with a long term goal of having the knowledge integrated into relevant employees
Ensuring product quality through implementation of Quality by Design (QbD) principles
Knowledge and Qualifications
Masters degree with over seven years of experience or Ph.D. with over five years of experience in the biotechnology, pharmaceutical, and medical device industry
Previous success commercializing biologics or medical devices at established companies, from beginning to end
Proven ability to mentor people leaders, scope a long-term vision for a department, and foster trust and collaboration with internal and external partners
A trusted expert in interpreting regulatory documents such as Code of Federal Regulations (CFR), United States Pharmacopeia (USP), Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) guidance documents
Broad knowledge of biological product development, testing, and commercialization including Quality programs required to support ISO, GMP or other regulated products
#Nonbench #LI-Hybrid #LI-ML1
STEMCELL Technologies is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. 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.
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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