Description
Ardelyx is a publicly traded commercial biopharmaceutical company 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). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
This is a 6 month contract, proximity to our Newark, CA is preferred for ad-hoc visits.
This role will provide QA support for Quality Systems and Compliance, with a primary focus on QA oversight of all Product Quality Complaints. The incumbent will work closely with functional teams to ensure that all product complaints are reviewed, processed, and communicated in a timely manner.
Duties include, but are not limited to, the day-to-day handling of quality complaints and other QA activities that ensure the effectiveness of the Pharmaceutical Quality System.
Position Responsibilities:
- Manage for all product complaint handling activities, from complaints receipt to closure.
- Record and process quality complaint information into the Product Complaint system, ensuring compliance with regulatory requirements and established procedures.
- Perform or coordinate complaint investigations, evaluate information from a technical perspective, and initiate corrective actions as needed.
- Conduct follow-up with reporters, cross functional departments and call center to gather additional information and issue response letters regarding product complaints.
- Review daily processes to ensure timely escalation of issues and communicate with management and team members to ensure appropriate actions are taken.
- Maintain accurate and current complaint documentation and ensure timely completion of tasks while adhering to quality standards.
- Identify and support process improvements to enhance efficiency and compliance in complaint handling.
- Perform other related duties as assigned based on company needs.
Position Requirements:
- Bachelor's degree or higher in a related scientific field or equivalent experience.
- 3-5 years of experience in a Quality environment, with demonstrated knowledge and proficiency in Quality System requirements.
- Practical understanding of CFR Title 21 (Parts 11, 210, and 211).
- Familiarity with FDA regulatory requirements, guidelines, and recommendations for product complaints.
- Broad experience with Quality Assurance systems and processes.
- Strong leadership, technical, management, attention to detail, problem-solving, and project management skills.
- Excellent communication, organizational, and interpersonal skills.
- Ability to present data, speak confidently, and defend approaches in front of audiences and inspectors.
- Experience with industry-standard enterprise system applications (QMS, EDMS).
- Proficiency in word processing and spreadsheet applications.
- Good knowledge of Good Documentation Practices (GDP) as they relate to complaint filing.
- Ability to work in a highly detailed environment, where mental focus and accuracy are essential.
The hourly range for this full-time contract position is $45.00 - $55.00. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers
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Ardelyx
Jul 02, 2025