Lead Corporate Quality Analyst

OPENTEXT - THE INFORMATION COMPANY
OpenText is a global leader in information management, where innovation, creativity, and collaboration are the key components of our corporate culture. As a member of our team, you will have the opportunity to partner with the most highly regarded companies in the world, tackle complex issues, and contribute to projects that shape the future of digital transformation.
AI-First. Future-Driven. Human-Centered.
At OpenText, AI is at the heart of everything we do—powering innovation, transforming work, and empowering digital knowledge workers. We're hiring talent that AI can't replace to help us shape the future of information management. Join us.
About PMO/Governance
The PMO/Governance plays a pivotal role in enabling strategic alignment, standardizing best practices, and ensuring consistent execution across enterprise programs and initiatives. Within the PMO organization, Governance supports the governance and continuous improvement of QMS processes by partnering with cross-functional teams to drive compliance, scalability, and operational efficiency. The PMO fosters collaboration across functions, ensuring quality processes are effectively integrated into the software development lifecycle and broader business initiatives.
**Your Impact**: As a Lead Quality Analyst, you will directly contribute to the effectiveness and scalability of enterprise QMS processes that impact compliance, audit readiness, and product development. Your leadership in managing critical quality functions—such as document control, training, audits, and validation—will help ensure that software systems meet industry standards and regulatory requirements. By collaborating with engineering, IT, and business stakeholders, you will influence continuous improvement efforts and strengthen the overall compliance posture of the organization
**As a Lead Quality Analyst, you will**:

- Manage key Quality Management System (QMS) processes including, but not limited to:

- Document Control
- Training Management
- Internal and External Audits
- Corrective and Preventive Actions (CAPA)
- Computer System Validation (CSV)
- Review and approve Software Development Lifecycle (SDLC) deliverables for process adherence; identify and address quality or compliance issues as needed
- Review and approve Computer System Validation (CSV) deliverables, such as Qualification Results, Validation Plans, and Validation Reports, ensuring compliance with process requirements and regulatory standards
- Support customer quality audits, including preparing audit evidence, coordinating dry-runs and audit sessions, taking notes, tracking follow-up actions, and leading remediation activities as required
- Contribute to M activities related to quality processes and audit readiness
- Manage engineering process deviations and CAPAs
- Drive continuous improvement initiatives by identifying opportunities to enhance software development and deployment processes, collaborating closely with cross-functional teams
- Maintain and update quality policies and procedures to ensure the QMS remains compliant and effective as applicable regulations, industry standards, and business needs evolve, in alignment with scheduled periodic reviews

**What you need to Succeed**:

- Bachelor’s degree in Computer Science, Life Sciences, or a related technical field
- Minimum 5 years of experience in Life Sciences or a similar regulated industry
- At least 3 years of experience in a Quality role within enterprise SaaS or equivalent environment
- Strong familiarity with IT systems and infrastructure used in regulated industries
- Solid understanding of quality assurance principles, QMS methodologies, and tools
- Experience working in FDA-regulated environments, including knowledge of 21 CFR Part 11 and Computer System Validation (CSV)
- Working knowledge of quality standards such as ISO 9001 and 21 CFR Part 820
- Strong grasp of SDLC processes and related deliverables (e.g., project charters, test plans, release reports)
- Excellent written and verbal communication skills
- Proficiency with tools such as JIRA, Confluence, and Microsoft Office Suite

Preferred
- Experience participating in audits, deviation investigations, and implementation of corrective actions
- Practical knowledge of GAMP 5, ISO 9001, applicable GxP guidelines, and other relevant regulatory requirements

**One last thing**:
OpenText is more than just a corporation, it's a global community where trust is foundational, the bar is raised, and outcomes are owned.
Join us on our mission to drive positive change through privacy, technology, and collaboration. At OpenText, we don't just have a culture; we have character. Choose us because you want to be part of a company that embraces innovation and empowers its employees to make a difference.
OpenText's efforts to build an inclusive work environment go beyond simply complying with applicable laws. Our Employment Equity and Diversity Policy provides directio