Manager, Quality Assurance, Business Operations Products

Job Description Summary

Work with key partners in supporting STEMCELL Technologies as a Quality Assurance Manager in our Business Operations team! We would love to hear from you if you are passionate about building relationships, whether it be through mentoring teams or traveling to grow our external partnerships.

You are excited about effectively assisting in the development and implementation of strategies to maintain the Quality Management System (QMS) as a whole. You are motivated by opportunities to exercise judgment in evaluating complex problems and applying current methodologies and practices to resolve identified issues. With your superb communication skills, you are a confident presenter and speaker who embodies our mission of Scientists Helping Scientists.

Job Description

Duties and Responsibilities

• Collaborate cross-departmentally with external and internal stakeholders to support product launches
  
• Establishes and maintains Quality systems required for the manufacture and distribution of STEMCELL products, including human biological materials
  
• Lead QA investigations on product complaints, corrective and preventative actions
  
• Develop metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive Continuous Improvement
  
• Participate in audits, responding to technical questions and assurance related matters
  

Knowledge and Qualifications

• Bachelors of Science in a life-science related field, with a minimum of 10 years of quality industry experience in the biotech regulated industry or equivalent
  
• Minimum of 5 years of management or supervisory experience, with the ability to leads multidisciplinary product improvement and development teams by providing information and technical support to meet team goals
  
• Experience with implementing and managing Quality Management Systems
  
• Extensive knowledge of QualityFlexibility for travel approximately twice a quarter
  
• System regulatory requirements (e.g., ISO 13485/9001, CE mark, FDA CFRs)
  

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.

To apply, please select the "Apply" button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.

Category

Quality Assurance