Senior IT Security, Risk & Compliance Analyst
Waltham, Massachusetts, United States
USD 145K-177K Senior-level Full Time
Tasks
- Advise project teams on validation scope and strategy
- Assess compliance risks and recommend mitigations
- Collaborate with IT Quality and business stakeholders
- Continuously improve compliance validation and risk processes
- Coordinate IT change management for compliance
- Ensure compliance with regulations and internal policies
- Execute computer systems validation activities
- Gather system and project requirements
- Investigate deviations deviations failures and issues
- Maintain validated application compliance status
- Perform audit readiness assessments
- Perform root cause analysis for nonconformances and CAPA
- Review system changes and provide compliance assessments
- Support internal and external audits
Perks/Benefits
- 401k Plan Employer Match
- Annual Winter Holiday shutdown
- Disability
- Equity incentive plans
- Flexible time off
- Health plans
- Life insurance
- Living organ and bone marrow leave
- Paid Holidays
- Paid parental leave
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | Audit Readiness | CAPA | CFR Part 11 | Cause analysis | Change Management | Computer Systems | Computer Systems Validation | Database Management | Database Management Systems | Development Lifecycle | Directory Services | Enterprise applications | GxP | Management systems | Part 11 | Regulatory Compliance | Risk Management | Root Cause Analysis | Root cause | Software Development Lifecycle | Software development | Storage | Systems Validation | Test Management | Test Planning | Testing | Validation Lifecycle | Virtualization
Education
Regions
Countries
States
Cities
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