Senior IT Security, Risk & Compliance Analyst
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.
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.
The Senior IT Security, Risk & Compliance Analyst 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 corporate governance requirements.
The Analyst partners with cross-functional teams to assess risk, support 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 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, collaborating 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 of non-conformances and CAPAs
- Support development and execution of computer systems validation activities in alignment with regulatory expectations
- Ensure IT systems and processes comply with applicable regulations and internal policies
- Identify compliance risks and recommend mitigation strategies to support secure and compliant system operations
- Collaborate with IT, Quality, and business stakeholders to support compliant system implementation and ongoing operations
- Contribute to continuous improvement of compliance, validation, and risk management processes
Qualifications:
- Bachelor’s degree, master’s degree preferred, with 8+ years of Computer Systems Validation or related experience in the life sciences industry or health sciences.
- 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
- Experience collaborating with cross-functional teams and aligning on validation strategy
- Experience validating enterprise applications and working experience with test management tools
- Ability to articulate risk-based validation strategy and provide validation approach to meet business needs
- Working knowledge of regulatory requirements, including 21 CFR Part 11 and other applicable GxP regulations
- 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.