Computer System Validation (CSV) Expert

As a CSV Expert you will play a key role ensuring that our software products are qualified in accordance with our quality management system. You will be involved in the development and delivery of cutting-edge software solutions for life science companies with your primary responsibility being to ensure that our software meets quality and regulatory standards. Specifically, you will:
Develop and Implement CSV Strategies: define qualifications approaches, including quality plans, test protocols, and risk assessments in compliance with GxP requirements.
Support GxP HIPAA Compliance: ensure product development and lifecycle activities adhere to regulatory standards such as FDA, EMA, HIPAA, and other relevant guidelines.
Ensure Data Security Integrity: oversee compliance with HIPAA regulations related to electronic Protected Health Information (ePHI), access controls, encryption, and audit logging within validated systems.
Oversee Qualification Processes and Document Qualification Activities: coordinate and lead qualification activities across our applications, while ensuring that all qualification documentation is complete, accurate, and audit ready.
Risk Management: develop risk management processes and ensure mitigation of risks related to system failures or non-compliance with GxP and HIPAA standards.
Facilitate Audits and Inspections: prepare for and support internal and external audits, ensuring applications and processes remain compliant and ready for regulatory scrutiny.
Maintain Compliance in Change Control: ensure proper qualification and documentation for system changes, upgrades, or migrations, aligning with GxP and HIPAA regulatory requirements.
Continuous Improvement: recommend and implement improvements across the product lifecycle process to enhance efficiency and compliance.