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 submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Note: Contractor hiring to full-time Conversion targeted within 3-6 months post start date.
Purpose of the role: The Quality Assurance Compliance Specialist III role is responsible for Document Control, Training program, Internal Deviations, CAPA , Quality Metrics reporting, and Management Review meetings. This role will report to the Manager of Quality Assurance Compliance. Position Responsibilities:
- Provide day-to-day administrative support for Electronic Document Management System (EDMS) and Learning Management System (LMS)
- Controlled documents (such as Policies, SOPs and Work Instructions) and Document Change Control related processes
- Periodic review of the controlled documents per SOP requirements
- Oversee company wide Training Program. Ensure appropriate training requirements are defined for all job roles and training records are readily retrievable
- Write, maintain and implement policies and supporting SOPs, Work Instructions/Forms and training materials for the Training Program
- Conduct orientation training for new hire employees
- Perform Change Control activities associated with the Training Program
- Complete daily workload while maintaining consistent, right first-time quality work and compliance with established procedures and timelines
- Identify and implement efficiency and compliance improvements to the training and controlled document management process
- Support Product Quality Complaint handling activities.
- Support internal deviation and CAPA processes
- Support the reporting of Quality metrics on a weekly, monthly, and quarterly basis
- Support Vendor Management
- Perform other related duties as assigned from time to time based on company needs
Position Requirements:
- Bachelors' or higher degree in sciences
- 3 - 5 years experience in a Quality environment, with exhibited knowledge and proficiency of Quality System requirements
- Practical understanding of CFR Title 21 (Parts 11, 210, and 211)
- Understanding and familiarity with FDA regulatory requirements, guidelines, and recommendations for product complaints
- Broad experience with Quality Assurance systems and processes
- Proficient with technical, problem solving and project management skills
- Excellent communication and organization skills required
- Ability to speak, present data, and defend approaches in front of audiences and inspectors
- Experience and proficiency with industry standard enterprise system applications (QMS, EDMS, LMS)
- Proficiency with word processing and spreadsheet
- Knowledge of Good Documentation Practices (GDP)
- Ability to work in a highly detailed environment where mental focus and accuracy of timely work output is essential
The anticipated annualized base pay range for this full-time position is $98,728-$120,668. 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 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.