Senior Program Manager, Quality Assurance, Human Biological Material
Job Description Summary
We are looking for a Senior Program Manager, Quality Assurance who can develop and implement activities in accordance to STEMCELL’s mission to supply innovative reagents, tools, and services. You would support the corporate-wide Quality Management System (QMS) required for the manufacture and distribution of our products by collaborating with internal and external groups. The Senior Program Manager will have the opportunity to develop new programs to guide the strategic direction of the company. STEMCELL is a dynamic workplace that pursues cutting-edge technologies and practices which translates to this role of managing complex sources of data that require in-depth critical thinking and reviewing the impact on the department and organization.Job Description
Duties and Responsibilities:
Capture the requirements and business strategies from Steering Committee and implement to ensure compliance and minimize risk to the organization
Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies
Create, manage and collaborate with key QMS programs such as but not limited to Change Control, CAPA, Documents and Records, and Specifications
Provide leadership to all staff as related to quality practices, requirements and regulation
Support the Quality and Regulatory team in day-to-day activities
Knowledge and Qualifications
Minimum Master’s or Bachelor’s Degree in relevant field (e.g. biology, chemistry, etc.) Over 10 years experience in quality assurance and/or regulatory in the biotech industry or equivalent
Good knowledge and demonstration of project management principles
Be comfortable in an uncertain environment
Excellent technical report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes
High level of critical thinking
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.
#Non-Bench #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 significant career development opportunities.
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Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number.Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!