Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as early-stage pipeline candidates.
We are seeking a highly skilled and detail-oriented QA Computer System Specialist to join our team. The ideal candidate will be responsible for overseeing the quality assurance for all GxP computer systems within our organization. The person in this role will work with the functional teams to ensure that all GxP regulated systems are purchased, audited, installed and maintained according to industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position will also support plan and organize QA activities for computer system validation projects.
Specific duties of this role include, but are not limited to, overseeing and approving validation- related documents, conducting risk assessments, determining which elements of projects should be validated, assessing and/or coordinating impact of proposed changes to computerized systems, and support activities to prepare for inspections (both external and internal) related to computer system validation. The candidate will also be responsible for maintaining GxP computer systems in a validated state in addition to support designing work processes for users and administrators of these systems.
In addition, this position will involve interacting with regulatory agencies and corporate partners during inspections and audits and may require travel to audit computerized system vendors off-site. The incumbent will also develop and implement strategies to ensure compliance with CSV requirements and consistent application of relevant policies and processes.
Position Responsibilities:
Note: The following is meant to be a representative but not necessarily all inclusive of the duties and responsibilities for this position:
Position Requirements:
Work Environment
Corporate office location in Fremont, CA. Hybrid will be considered. Willingness to travel up to 10% of time within the U.S.
As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients. It's the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines. We are different for good.
The anticipated annualized base pay range for this full-time position is $90,000-$110,00. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.Actual base paywill be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include anannual 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 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.