Senior Manager, Computer System Validation
Job Description SummarySTEMCELL Technologies is seeking an exceptional Senior Manager of Computer System Validation (CSV) to lead our efforts in ensuring compliance and driving excellence in computerized systems. As a key member of our Quality team, reporting directly to the Director of Quality, you will spearhead the Computer Systems Validation and Compliance of our cutting-edge technologies, empowering our scientific breakthroughs and lifesaving advancements.
We are looking for an inspirational leader who thrives on challenges and excels in risk management. Your expertise will be instrumental in guaranteeing adherence to essential regulations as you oversee the validation process from inception to completion. You will play a pivotal role in managing operations for CSV, collaborating closely with cross-functional teams and acting as their trusted guide, imparting validation principles and requirements throughout the entire system lifecycle.
Duties and Responsibilities
Providing invaluable guidance and interpretation of global GxP guidance and regulations for our computerized systems, electronic records, electronic signatures, and data integrity requirements such as 21 CFR Part 11 and EU Annex 11
Collaborating with cross-functional Business and System Owners, lending your expertise in the planning, execution, and implementation of GxP computerized systems
Responsible for Quality oversight of data integrity to the accuracy, consistency, and completeness of data throughout its lifecycle
Serve as the Quality technical reviewer for system implementations and other change controls to ensure regulatory compliance and internal requirements are met
Facilitate Periodic Reviews for systems, and ensure adherence to the internal Periodic Review schedule
Knowledge and Qualifications
Requires a Bachelor’s Degree with at least 10 years of GxP experience in a pharmaceutical or biotechnology or medical device industry with at least 5 years of applicable Computer System Validation experience
A minimum of 5 years of leadership experience
Experience with the implementation of computer systems across GxP functions (i.e., GMP, GCP, or GLP) is required
Working knowledge of FDA 21 CFR Part 11 regulations and applicable regulatory and industry guidance. Knowledge and understanding of GAMP5 is preferred
Ability to think strategically and to proactively identify issues
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 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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