Senior Quality Information Systems Specialist

Ardelyx•Waltham, MA

7d•Hybrid

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. Position Summary: The Senior Quality Information Systems Specialist is responsible for supporting 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. The Senior Specialist partners with cross-functional teams to assess risk, support system validation efforts, and ensure audit readiness across IT systems and projects. This role contributes to the execution of compliance processes, including change management, validation, lifecycle activities, and issue resolution. This is a hybrid role (2-3 days in office) at our Waltham, MA or Newark, CA office.

Requirements

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
Ability to articulate risk-based validation strategy and provide validation approaches to meet business needs
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

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 FDA
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