Location: Canada, ON, Richmond HillApply Now
The Senior Life Sciences Quality Analyst is responsible for building and ensuring sufficient controls and processes comply with quality regulations and support associated audits from customers in the Life Sciences industry. Life Sciences industry customers are required to validate software systems that they use, particularly for manufacturing, quality assurance and clinical trials. As a software vendor to the Life Sciences industry, OpenText must support these customers by having clear, documented processes, procedures and controls in place to assure that our software products are well tested, secure from vulnerabilities and meet functional requirements.
You are great at:
• Translating relevant regulatory requirements to IT technical teams as well as articulating how technical solutions meet quality requirements for customers.
• Collaborating across functions and stakeholders to ensure documented project/validation deliverables meet business and regulatory requirements.
• Providing quality guidance (including validation strategy) for software development and deployment to Commercial cloud to ensure compliance to GAMP5 guidance, Part 11, and other applicable regulatory requirements.
• Hosting customer audits, following up on customer audit reports and managing remediation as necessary. Supporting the development and execution of audit readiness programs and quality initiatives.
• Preparing OpenText’s responses to pre-sales contracts; customer audit reports, ensure appropriate identification and communication of action plans.
• Assisting the Quality Management Director in providing quality control over procedures and work instructions and may assist in conducting periodic internal audits of software programs.
• Identifying and securing resources for and driving to completion key process improvement initiatives to improve software development processes, controls and compliance.
• Providing assurance to executive management regarding the effectiveness of controls and processes in enabling compliance with Life Sciences industry quality expectations of software vendors.
What it takes:
• 4 to 5 years of Life Sciences Quality experience with knowledge of Validation Lifecycle Approach
• 4 to 5 years of Software Development Program Management
• Knowledge of Systems Development Life Cycle (SDLC)
• Knowledge of GAMP5 – Risk-Based Approach to Compliant GxP Computerized Systems
• Possess system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5)
• Results driven influencer with the ability to lead, motivate and mentor a team
• Ability to communicate effectively with, and work closely with senior management
• Meticulous and diligent attention to detail
• Strong written & verbal communication skills
• Bachelor’s degree in a related field
At OpenText we understand and value diversity in our employees and are proud to be an Equal Opportunity Employer. We hire the best talent regardless of sex, national origin, disability or race. If you require accommodation at any time during the recruitment process please email firstname.lastname@example.org.