Quality Assurance Manager
22 hours ago
**Job Description Summary**:
You are someone who consistently demonstrates quality, whether it is through the integrity of a Quality Management System (QMS), your communication with colleagues, or mentorship of your team. As a Quality Assurance Manager in our Operations team, you are driving our Aseptic Process Simulation (APS), and validating processes to compliance regulations to ensure we continuously meet our quality standards and outstanding product quality. Working with high-visibility and critical components, you are collaborative, confident, and swift when addressing complex problems. You empathize with peers across departments and address concerns in a thoughtful and critical manner to address risks appropriately. If you are someone who is looking to build roots within the largest biotechnology company within Canada, this role would create a path for you to grow your career in Quality, and provide opportunities to lead projects, as well as lead staff and support their career development.
**Duties and Responsibilities**
- Manage GMP Manufacturing Operation related tasks, such as line clearance, and oversee Quality related events such as investigations, CAPAs, product complaints, and change controls
- Develop, monitor, and report KPIs and metrics that report on the effectiveness of processes, status of improvement opportunities, and progress against performance objectives to drive Continuous Improvement (CI)
- Effectively lead direct reports and manage hiring and developing staff skills via training, coaching, mentoring, and motivating staff
- Actively participate with the introduction of new facility sites for production of GMP products and ensure that these new site(s) meet compliance regulations
- Maintain the cleanroom site Inspection Readiness Program, and actively participate and support internal regulatory and customer audits related to GMP Manufacturing Operations
**Knowledge and Qualifications**
- Minimum 10 years’ experience in quality assurance process improvement in the biotech regulated industry or equivalency
- Clean room environment experience, with introduction of new facility experience is an asset
- Flexibility to address urgent matters outside of regular business hours, including early mornings, evenings, and weekends
- Extensive knowledge of Quality System regulatory requirements, including ISO 13485/9001, CE mark, and FDA CFRs
- Extensive GMP knowledge is a must
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.
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