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STEMCELL Technologies

Senior Manager, Quality Assurance

Vancouver, BC
Full Time
3 days ago
Job Description Summary

Are you looking to develop and implement strategies for New Production Introduction of our regulated products? If you are looking for an opportunity to exercise your judgment in evaluating complex problems within the fast-paced and dynamic biotechnology sector, then you may be the person we're looking for!

As a Senior Manager within the Quality Assurance Department at STEMCELL Technologies, you will be in consultation with our Research and Development and Technical Operations Teams to manage the new product introduction and commercialization of our ancillary materials and medical devices. Working closely with external and internal stakeholders, you will build relationships, and serve as an educator to support collaborations in the life cycle management of our products. Your expertise will provide fundamental knowledge to guide processes, validations, and decisions impacting compliance, product quality and operational efficiency.

Job Description

Duties and Responsibilities
  • Establish and maintain Quality systems required for new product introduction, technology transfer, manufacture and distribution of new and regulated STEMCELL products
  • Leads QA evaluations, and creation and execution of quality strategic planning to ensure compliance and business needs
  • Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement
  • Leads multidisciplinary product and process improvement and development teams by providing compliance and technical support to meet team goals
  • Exercises independent judgment in reviewing and approving risk assessments, evaluations, protocols, reports and other QMS documentation

Knowledge and Qualifications
  • At least 10 years' experience combined in quality unit and manufacturing in the biotech regulated industry or equivalent
  • GMP experience in biotechnology, pharmaceutical, or life science field is required
  • Extensive knowledge of Quality System regulatory requirements, including 21 CFR 820, 21 CFR 210 and 211
  • Previous managerial experience required
  • Willing and able to travel once per quarter to conduct audits

This role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.

#Nonbench #LI-Hybrid

STEMCELL Technologies Inc. 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 with boosters) against COVID-19, as currently recommended or required by local health authorities and public health orders.

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Quality Assurance