Job Summary
The Project and Process Quality Auditor ensures that customer specific configured software solutions meet internal quality standards, client specifications, and regulatory requirements. This role involves auditing processes, configurations, and deliverables to verify compliance, accuracy, and consistency. The Project and Process Quality Auditor collaborates with project managers, functional and technical consultants, configurators, and compliance teams to audit and confirm that each project is executed per the established project specific governance framework.
Key Responsibilities
- Audit Project documentation including existence of charter, project plan, project specific solution implementation checklists for the project managers to use.
- Audit the deployment of the required number of environments, access controls and other technical capabilities to execute the project deployment
- Audit customer specific software configuration sprints to verify that the development process for configurations are followed including the existence of approved requirements with positive and negative test cases (when relevant), time estimations and customer signoffs
- Verify the execution of developer unit tests and functional consultant tests before being authorized to package and deploy for customer review / verification and sign-off
- Verify configuration deployments are following the established deployment protocols
- Any defects that escape into UAT or production, will need to be documented as NCs and verify that the identified root cause analysis is conducted and signed off
- Audit and verify the existence of all the quality documentation per project in the project folder
- Handle NCs and CAPAs identified during audits or reported by customers. Track resolution progress and ensure timely closure of all issues.
- Collaborate with cross-functional teams (development, QA, compliance) to resolve issues and implement improvements.
- Develop and deliver training programs for new personnel on project quality processes.
- Support external audits and client reviews by ensuring documentation and evidence are complete and accurate.
- Maintain current on all assigned internal CQ training as assigned in the CQ-QMS
- Comply with all internal CQ Quality and Information Security requirements
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, Information Systems, Quality Management, or related field.Minimum of 3+ years of Project / Delivery quality auditing experienceStrong understanding of software delivery process and SDLC.Minimum of 2+ years of Software auditing experiencveKnowledge of ISO 9001, GxP, or similar standards.Preferred Skills
Experience with configuration management tools (e.G., Jira, Confluence, Jenkins).Exposure to regulated environments (e.G., life science, healthcare).Strong analytical, problem-solving, and communication skills.Soft Skills
Detail-oriented with a proactive approach to identifying risks.Ability to work independently and collaboratively.Excellent organizational and time-management skills.