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Senior Quality Analyst

Req id:  33302

Waterloo, ON, CA Richmond Hill, ON, CA



As the Information Company, our mission at OpenText is to create software solutions and deliver services that redefine the future of digital. Be part of a winning team that leads the way in Enterprise Information Management. 



What You Will Do:


  • As member of team to manage activities to ensure compliance and effectiveness of the Life Sciences Governance program that supports OpenText products/services in the Life Sciences vertical:
    • Review and approve of Software Development Lifecycle (SDLC) deliverables and address issues.
    • Review and approval of Computer System Validation (CSV) deliverables (Validation Plan/ Qualification Results/ Validation Report and deviation management).
    • Support and manage LS audits (gather evidence, present, and remediate issues). Answer / clarify related questions (in coordination with all other applicable company groups) regarding the development/release of on-prem/cloud products.
    • Support audit questionnaires.
    • Support Life Sciences RFIs/RFPs.
    • Ensure compliance and effectivity of established cross-functional SOPs from development to deployment.
    • Ensure cross-functional teams follow established processes.
    • Manage process improvement activities.
    • Support application change management in a regulated environment
  • Ongoing expansion/development of Validation processes for Life Sciences vertical services
  • Support OpenText mega-compliance audits (ISO/PCI/HIPAA/SOC/FedRamp, etc.).
  • Assist in OpenText M&A activities regarding Engineering processes.




  • Bachelor’s degree in Computer Science or related technical field.
  • Experience and working knowledge in FDA-regulated categories such as pharmaceutical, 21 CFR Part 11, and computer system validation.
  • Working knowledge of QMS (ISO 9001, 21 CFR Part 820).
  • Experience and working knowledge with software development lifecycle and understanding deliverables such as project charter, test plan, test summary, and release report.
  • Working high-level knowledge of cloud deployments.
  • Excellent communication skills, both written and verbal
  • Experience and familiarity using tools like JIRA, Confluence, MS Office.
  • Working knowledge in process improvement.



OpenText's efforts to build an inclusive work environment go beyond simply complying with applicable laws. Our Employment Equity and Diversity Policy provides direction on maintaining a working environment that is inclusive of everyone, regardless of culture, national origin, race, color, gender, gender identification, sexual orientation, family status, age, veteran status, disability, religion, or other basis protected by applicable laws. Should you require accommodations during the selection process, please contact


Our growing team is mapping the future of Information Management, and we continue to make new discoveries that expand its boundaries. Join us and be part of a winning team, where the opportunities for your career are limitless. 

From its innovative start as a research project by University of Waterloo professors in 1991, OpenText has grown into a global company with offices in more than 35 countries. Our high- performance culture has forged our growth and is an excellent fit for people looking to push themselves to learn and do more.

It’s our time to lead, and as part of our team, it will be your time too. Our continued growth will provide you the opportunity to explore, learn and chart an exciting career path while enjoying a good work-life balance. 

If you thrive in a dynamic work environment, there is always a new horizon to explore. We are proud to offer excellent benefits, challenging work and competitive financial rewards. 

Our employee programs prioritize employees’ well-being and that of their families. We offer a comprehensive benefit plan, education assistance, a wellness/fitness reimbursement and time off to volunteer. 

Social events 
With offices around the world and flexible work arrangements, OpenText strives to make sure all our employees feel connected. Teamwork extends to our social lives too from local social events to company-wide activities, we want our employees to take time to relax and have fun.  

Corporate Citizenship  
Corporate Citizenship is more than a program for us, it is engrained in our purpose, impact, and approach to doing business. Through numerous volunteer initiatives, we support education and innovation for global change.

Explore your career and potential. Become an OpenText Navigator.

Apply now »