DescriptionPosition 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
- 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
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.
