Senior Quality Information Systems Specialist

Position Summary

The Senior Quality Information Systems Specialist supports IT compliance, risk management, and computer systems validation activities within a regulated life sciences environment. This role ensures that IT systems and processes meet applicable regulatory, security, and GxP or FDA requirements.

Responsibilities

• Advise IT Leadership, project teams and internal Ardelyx customers on validation scope, risk, and validation approach
• Maintain and manage the status of validated applications
• Administer audit readiness checks, specifically for GxP and/or FDAP
• Participate in project and system requirements and coordinate activities with business users and analysts
• Partner with Quality Assurance to coordinate the Change Management process within the GxP organization
• Review system changes to provide compliance assessments and closure summaries that are audit ready
• Investigate root-cause of defects, failures, and authors and/or investigate non-conformances and CAPAs, including recommend changes for process improvements
• Provide recommendations and work collaboratively with other team members to achieve organizational goals
• Track key performance indicators, analyze data, and report on team progress to senior management
• Manage projects and operations, ensuring that resources are used effectively
• Address and resolve conflicts within the team and with cross functional teams, fostering a positive and productive work environment

Qualifications

• Bachelor’s degree with 8+ years of Computer Systems Validation or related experience in the life sciences industry or equivalent experience
• Experience validating enterprise applications and working experience with test management tools
• Strong oral and written skills to persuade, direct and advise stakeholders on regulatory compliance processes
• Experience validating enterprise applications and working experience with test management tools
• Strong organizational skills to maintain and manage multiple validation projects
• Ability to work with cross-functional teams and aligning on validation strategy
• Experience with regulations– e.g., 21 CFR Part 820/11
• Experience with software development lifecycle activities, methodologies, testing, and validation
• Experience with common IT infrastructure and applications, e.g., virtualization, directory services, storage, DBMS