Senior Quality Information Systems Specialist - IT

ardelyx; Waltham (MA); On-site; USD 145,000 - 177,000; Full time

Benefits offered by this job

401(k) plan with employer match

Paid parental leave

Living organ and bone marrow leave

Equity incentive plans

Health plans (medical, prescription, p

Dental and vision

Life insurance and disability

Flexible time off

Winter Holiday shutdown

Paid holidays

Job summary

Ardelyx is seeking a Senior Quality Information Systems Specialist to support IT compliance, risk management, and computer systems validation in a regulated life sciences environment. You will work with cross-functional teams to ensure audits readiness and validate enterprise applications, with a hybrid work arrangement in Waltham, MA or Newark, CA.

The role focuses on change management, lifecycle activities, and addressing CAPAs within GxP and FDA requirements, collaborating with Quality

Qualifications

• Bachelor’s degree with 8+ years of Computer Systems Validation in life sciences.
• Experience validating enterprise applications and test management tools.
• Strong oral and written skills for regulatory compliance.
• Ability to lead cross-functional validation efforts and risk-based approaches.
• Familiarity with 21 CFR Part 820/11 and lifecycle activities.

Responsibilities

• Advise IT Leadership and teams on validation scope, risk, and validation approach.
• Maintain and manage the status of validated applications.
• Administer audit readiness checks for GxP and FDA.
• Coordinate requirements with business users and analysts.
• Coordinate Change Management within the GxP organization with QA.
• Review system changes for compliance assessments and audit-ready closure.
• Investigate defects and non-conformances and recommend improvements.
• Collaborate to achieve organizational goals and report KPIs.
• Manage projects/resources and address cross-functional conflicts.

Skills

Computer Systems Validation

Regulatory compliance

Communication skills

Cross-functional collaboration

Organizational skills

Software development lifecycle

IT infrastructure familiarity

Education

Bachelor’s degree

Tools

Test management tools

Job description

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.

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

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
• 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

The anticipated annualized base pay range for this full-time position is $145,000 - $177,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.