Senior Quality Analyst

OPENTEXT - THE INFORMATION COMPANY

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.

Qualifications

• 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 accommodationrequests@opentext.com.