Our Quality Assurance (QA) team at Trialspark is looking for an experienced Quality Software Engineer to participate in the ongoing implementation of our Software Quality Management Systems (QMS) and Software Development Life Cycle (SDLC) processes in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls. This role is embedded within the engineering and product teams to help continuously qualify and validate our software tools.
- Independently review Good Practices (GxP) Document Deliverables as a Subject Matter Expert (SME), approving/authorizing key documents such as User Requirements Specifications, Validation Plan, Risk Assessment, Test Protocols/Reports, Validation Summary Report, and releasing systems into production;
- Ensure GxP document deliverables are consistent and in compliance with corporate policies and procedures following Food and Drug Administration (FDA) regulations, and facilitate a risk-based lifecycle approach form business process description through system retirement;
- Guide in System Validation of Software as a service (Saas) tools for study-specific intended use, Data Integrity, Code of Federal Regulations (CFR) 21 Part 11 Compliance, Audit Preparation and Support, Data Migration, and Release and Change Management Process;
- Work in close collaboration with Engineering and Product Teams;
- Investigate validation discrepancies, drive deviation management, and create best-practices for system validation including Computer System Validation (CSV) training and workshops;
- Serve as Software SME in support of audits and regulatory inspections;
- Manage Tech (Engineering, Product & Data) incident management program, including intake, evaluation, triaging, query, assignment, investigation, corrective action and reporting;
- Maintain and organize the incident management database, creating relevant tracking reports, cases statuses, dashboards, summaries and executive reports;
- Drive the planning, implementation, administration and communication of data privacy across the org;
- Establish and oversee TrialSpark’s standards and practices for the collection, use, transfer, storage and deletion of personal information;
- Support the compliance risk management efforts including gap assessments and corrective action plans;
- Conduct audits, both internal and external;
- Work with Internal audit, external auditors, management, and staff to identify feasible resolutions to control gaps and opportunities for improvement.
- You have a degree in Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field
- You have at least 3 years of relevant experience in software validation and change management in the pharmaceutical industry.
- You have a deep understanding of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements and good documentation practices.
- You have demonstrated strong project management skills and enjoy working collaboratively with software development teams.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.