Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx’s cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.
QA Specialist I-III (CSV)
Purpose of the role:
This role will be responsible for QA oversight of all GxP Computer Systems Validation. The incumbent, working with the functional teams must ensure that all GxP regulated systems are purchased, audited, installed and maintained based on industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position plans and organizes all QA activities for computer system validation projects. Duties include, but are not limited to, oversight and approval of validation - related documents, leading risk assessments and working with project team to determine which elements should be validated, conducting and/or coordinating impact assessments of proposed changes to computerized systems and leading inspection (external/internal) readiness activities related to computer system validation. The candidate will ensure that all GxP computer systems are maintained in a validated state in addition to designing work processes for users and administrators of the aforementioned systems.
This position will interact with regulatory agencies and corporate partners during inspections and audits, and will require travel for auditing computerized system vendors off -site. The incumbent will develop and execute strategies to ensure CSV compliance and consistent application of these policies/processes.
As a member of the Ardelyx team, you will help us in developing and bringing to market first in class medicines to better the lives of underserved patients with cardiorenal diseases. 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 seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture and research environment.
Ardelyx, Inc. is an Equal Opportunity Employer.