Associate Director, Quality Auditing & Compliance

Ardelyx; Newark (CA); Hybrid; USD 188,000 - 230,000; Full time

Benefits offered by this job

401(k) plan with generous employer mix

12 weeks of paid parental leave

Living organ and bone marrow leave

Job summary

Ardelyx is seeking an Associate Director, Quality Auditing & Compliance to lead its risk-based internal audit program and ensure GxP compliance across the organization. This hybrid role supports regulatory readiness and continuous improvement of the QMS.

The role requires 2-3 days onsite per week at the Newark, CA or Waltham, MA offices, with 30-40% travel. You will partner with cross-functional teams to drive CAPAs and strengthen quality culture across Ardelyx.

Qualifications

• Bachelor's degree in life sciences, pharmacy, engineering, or related discipline.
• 8-10 years of progressive experience in Quality Assurance, Quality Compliance, auditing, or related functions within the pharmaceutical or biotechnology industry.
• Significant experience conducting and leading GxP audits and compliance assessments; experience across multiple GxP disciplines strongly preferred
• Strong knowledge of FDA regulations, ICH guidelines, Quality Systems, CAPA, data integrity, and applicable global regulatory requirements
• Ability to travel domestically and internationally 30-40%

Responsibilities

• Develop, maintain, and execute the annual risk-based internal audit program across applicable GxP areas and Quality Systems
• Plan, lead, document, and perform audits and other compliance assessments, ensuring clear identification and communication of observations and compliance risks
• Evaluate compliance with applicable FDA regulations, ICH guidelines, global regulatory requirements, company procedures, and established industry standards
• Partner with functional stakeholders to develop appropriate CAPAs and monitor remediation through timely and effective closure
• Identify systemic trends and emerging compliance risks and communicate significant findings, metrics, and recommendations to Quality leadership
• Support regulatory inspection readiness, mock inspections, health authority inspections, and post-inspection remediation activities
• Provide Quality Compliance guidance to cross-functional teams and promote a culture of Quality, accountability, scientific rigor, and continuous improvement
• Contribute to the development and improvement of Quality policies, procedures, audit methodologies, compliance metrics, and governance processes
• Maintain current knowledge of evolving regulatory expectations and industry practices and assess their potential impact on the organization

Skills

Quality auditing

Regulatory compliance

Risk assessment

Communication

Leadership

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

Audit management software

Quality Management System (QMS)

Job description

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:

• Develop, maintain, and execute the annual risk-based internal audit program across applicable GxP areas and Quality Systems
• Plan, lead, document, and perform audits and other compliance assessments, ensuring clear identification and communication of observations and compliance risks. This includes onsite audits of internal, external, and vendor/third-party audits
• Evaluate compliance with applicable FDA regulations, ICH guidelines, global regulatory requirements, company procedures, and established industry standards
• Partner with functional stakeholders to develop appropriate corrective and preventive actions (CAPAs) and monitor remediation through timely and effective closure
• Identify systemic trends and emerging compliance risks and communicate significant findings, metrics, and recommendations to Quality leadership
• Support regulatory inspection readiness, mock inspections, health authority inspections, and post-inspection remediation activities
• Provide Quality Compliance guidance to cross-functional teams and promote a culture of Quality, accountability, scientific rigor, and continuous improvement
• Contribute to the development and improvement of Quality policies, procedures, audit methodologies, compliance metrics, and governance processes
• Maintain current knowledge of evolving regulatory expectations and industry practices and assess their potential impact on the organization

Requirements:

• Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, engineering, or a related discipline
• 8 - 10 years of progressive experience in Quality Assurance, Quality Compliance, auditing, or related functions within the pharmaceutical or biotechnology industry.
• Significant experience conducting and leading GxP audits and compliance assessments; experience across multiple GxP disciplines strongly preferred
• Strong knowledge of FDA regulations, ICH guidelines, Quality Systems, CAPA, data integrity, and applicable global regulatory requirements
• Demonstrated ability to independently assess complex compliance issues, apply risk-based judgment, and influence effective remediation
• Experience supporting regulatory inspections and organizational inspection-readiness activities
• Strong written and verbal communication skills, including the ability to communicate audit findings and compliance risks effectively to senior leadership
• Auditor certification or equivalent professional certification preferred
• Ability to operate independently, exercise sound judgment, and influence cross-functional stakeholders without direct authority
• Ability to travel domestically and internationally 30 - 40%

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:

• 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
• 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.