Senior IT Security, Risk & Compliance Analyst
Ardelyx, Inc.
9 hours ago
Remote friendly (Waltham, MA)
United States
IT
Responsibilities:
- Advise project teams and stakeholders on validation scope, risk, and validation strategies
- Maintain and manage the status of validated applications to ensure ongoing compliance
- Perform audit readiness assessments and support internal and external audits
- Participate in system and project requirements gathering with business users and technical teams
- Coordinate and support IT change management processes to ensure compliance with validation and regulatory requirements
- Review system changes and provide compliance assessments, including audit-ready documentation and closure summaries
- Investigate systems issues, deviations, and failures, including root cause analysis and support for non-conformances and CAPAs
- Support development and execution of computer systems validation activities aligned with regulatory expectations
- Ensure IT systems and processes comply with applicable regulations and internal policies
- Identify compliance risks and recommend mitigation strategies for secure, compliant system operations
- Collaborate with IT, Quality, and business stakeholders for compliant system implementation and operations
- Contribute to continuous improvement of compliance, validation, and risk management processes
Qualifications:
- Bachelor’s degree; Master’s degree preferred; 8+ years of Computer Systems Validation or related experience in life sciences/health sciences
- Strong oral and written skills to advise stakeholders on regulatory compliance processes
- Strong organizational skills; ability to manage multiple validation projects
- Experience collaborating cross-functionally to align on validation strategy
- Experience validating enterprise applications and with test management tools
- Ability to articulate risk-based validation strategy
- Working knowledge of regulatory requirements (including 21 CFR Part 11 and other applicable GxP)
- Experience with software development/lifecycle activities, methodologies, testing, and validation
- Experience with common IT infrastructure/applications (e.g., virtualization, directory services, storage, DBMS)
- Advise project teams and stakeholders on validation scope, risk, and validation strategies
- Maintain and manage the status of validated applications to ensure ongoing compliance
- Perform audit readiness assessments and support internal and external audits
- Participate in system and project requirements gathering with business users and technical teams
- Coordinate and support IT change management processes to ensure compliance with validation and regulatory requirements
- Review system changes and provide compliance assessments, including audit-ready documentation and closure summaries
- Investigate systems issues, deviations, and failures, including root cause analysis and support for non-conformances and CAPAs
- Support development and execution of computer systems validation activities aligned with regulatory expectations
- Ensure IT systems and processes comply with applicable regulations and internal policies
- Identify compliance risks and recommend mitigation strategies for secure, compliant system operations
- Collaborate with IT, Quality, and business stakeholders for compliant system implementation and operations
- Contribute to continuous improvement of compliance, validation, and risk management processes
Qualifications:
- Bachelor’s degree; Master’s degree preferred; 8+ years of Computer Systems Validation or related experience in life sciences/health sciences
- Strong oral and written skills to advise stakeholders on regulatory compliance processes
- Strong organizational skills; ability to manage multiple validation projects
- Experience collaborating cross-functionally to align on validation strategy
- Experience validating enterprise applications and with test management tools
- Ability to articulate risk-based validation strategy
- Working knowledge of regulatory requirements (including 21 CFR Part 11 and other applicable GxP)
- Experience with software development/lifecycle activities, methodologies, testing, and validation
- Experience with common IT infrastructure/applications (e.g., virtualization, directory services, storage, DBMS)