Eryu Shang

• Work closely with the CSV manager to support IT compliance efforts, including the development and execution of validation protocols (IQ, OQ, PQ) for IT systems in accordance with GMP and FDA guidelines
• Lead IT-related change control processes, ensuring all system modifications are documented, evaluated for compliance impact, and implemented following proper approval processes
• Write and maintain critical compliance documentation, including validation protocols,change control records, and standard operating procedures (SOPs) to ensure IT systems regulatory standards
• Ensure IT systems are prepared for internal and external audits by maintaining comprehensive and up-to-date documentation. Provide direct support during GMP, FDA,and other regulatory audits, addressing IT-specific compliance questions
• Manage IT security protocols, including user account administration and door access control, ensuring that all user activities comply with industry standards and internal policies

Cybersecurity Project Manager

• Lead the development and deployment of a new threat detection system, improving real-time identification and mitigation of security risks.
• Coordinate with cross-functional teams to align the system with organizational security policies and industry compliance standards.
• Managed project timelines, budgets, and resources to ensure successful system deployment, enhancing overall cybersecurity posture.

Data Security Analyst

• Implement data security protocols to protect sensitive information and comply with regulatory standards.
• Conduct regular audits of data handling processes, identifying vulnerabilities and ensuring corrective measures.
• Analyze security incidents, contributing to risk mitigation strategies and improved data protection measures.

• Collaborate with scrum teams to develop and execute test strategies for feature validation, ensuring system reliability.
• Document and communicate defects, working to prioritize and resolve issues to enhance software quality.
• Configure and maintain test environment

• Provide first-level support for desktops, laptops, mobile devices, and applications, ensuring smooth IT operations.
• Assist with onboarding, PC/MacBook setup, and IT asset management.
• Support the IT team in maintaining hardware, software, and other systems