Director, Development and Safety Quality

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.

Position Summary:

The Director, Development and Safety Quality will provide independent quality oversight of clinical development, nonclinical, and pharmacovigilance activities for Ardelyx’s investigational and marketed products. This role will support compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practices (GVP), with a particular emphasis on pharmacovigilance and drug safety quality.

The Director will partner closely with Clinical Development, Clinical Operations, Nonclinical Development, Drug Safety, Regulatory Affairs, and external partners to maintain effective quality systems, drive inspection readiness, and address compliance risks. This position combines functional leadership with hands-on execution across audits, quality investigations, corrective and preventive actions, and continuous improvement.

Responsibilities:

Provide Quality guidance to development and drug safety teams on compliance requirements, risk assessments, and process improvements

Oversee quality events, investigations, and corrective and preventive actions (CAPAs), ensuring timely resolution and effectiveness

Lead assigned inspection of readiness activities and support regulatory inspections, responses, and remediation

Develop and maintain relevant quality policies and SOPs and provide Quality review of key development and safety documents

Support vendor and partner qualification processes, including applicable quality and safety data exchange agreements

Ensure quality oversight of vendor and partners across development and safety

Support risk-based audit activities across development and safety, including providing timely input to the PV quality audit program and oversight of findings through resolution

Monitor quality metrics, communicate emerging risks, and lead training and continuous improvement initiatives

Provide oversight and mentoring to assigned staff, auditors, and consultants, and support resource and budget planning.

Please note:

this position is a hybrid based out of our Waltham, MA office and requires presence on-site 2-3 days per week.

Qualifications:

Bachelor’s degree in a scientific discipline or related field with 12+ years of relevant pharmaceutical or biotechnology experience, including at least 5 years in GCP, GLP, or PV Quality, or equivalent experience

Strong expertise in PV Quality and drug safety compliance, with working knowledge of GCP, GLP, and applicable global regulations and guidance

Demonstrated experience conducting risk-based audits and supporting regulatory inspections, including responses and remediation

Experience managing quality investigations, CAPAs, quality metrics, and vendor oversight

Working knowledge of quality systems, computerized system validation, data integrity, and electronic records requirements

Demonstrated ability to identify and resolve quality issues through practical, risk-based decisions and timely escalation

Proven ability to lead cross-functional initiatives, influence stakeholders, and build effective internal and external partnerships

Strong written, verbal, and presentation skills, with the ability to communicate quality risks…