Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive.
We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve.
This is hybrid role with 2-3 days per week onsite in our Waltham, MA or Newark, CA office.
Position Summary:
The Associate Director, Quality Auditing & Compliance is responsible for leading and executing the company’s risk-based internal Quality audit program to assess compliance with applicable GxP regulations, regulatory requirements, company policies, and Quality standards. This role provides an independent, objective assessment of Quality System effectiveness, identifies and evaluates compliance risks and improvement opportunities, and partners with functional leaders to ensure timely and sustainable remediation of identified issues.
The position serves as a senior Quality Compliance subject matter expert and supports organizational inspection readiness, regulatory intelligence, and continuous improvement of the Quality Management System (QMS).
Responsibilities:
Requirements:
The anticipated annualized base pay range for this full-time position is $188,000-$230,000. 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.
Ardelyx is an equal opportunity employer.
We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.