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.

Job description

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 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

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 and recommendations clearly
Ability to manage competing priorities and meet critical deadlines in a fast-paced, evolving environment
Ability to travel domestically and internationally up to 20%

Requirements

Bachelor's degree in a scientific discipline or related field
12+ years of relevant pharmaceutical or biotechnology experience
At least 5 years in GCP, GLP, or PV Quality
Strong expertise in PV Quality and drug safety compliance
Working knowledge of GCP, GLP, and applicable global regulations and guidance
Demonstrated experience conducting risk-based audits and supporting regulatory inspections
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
Ability to manage competing priorities and meet critical deadlines
Ability to travel domestically and internationally up to 20%

Benefits

401(k) Matching
Paid Parental Leave
Organ & Bone Marrow Leave
Equity Incentive Plans
Medical, Dental & Vision
Life Insurance
Disability Insurance
Flexible Time Off
Winter Holiday Shutdown
11 Paid Holidays

Company overview

Ardelyx, Inc. is a biopharmaceutical company founded in 2007 and headquartered in Fremont, California, with additional offices in Waltham, Massachusetts. The company specializes in discovering, developing, and commercializing innovative, first-in-class medicines that address significant unmet medical needs. Ardelyx has developed a unique platform that enables the discovery of novel biological mechanisms and pathways to create potent and efficacious therapies while minimizing side effects and drug-drug interactions commonly associated with traditional systemically absorbed medicines. The company currently has two FDA-approved commercial products: IBSRELA® (tenapanor) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C), and XPHOZAH® (tenapanor) for reducing serum phosphorus in adults with chronic kidney disease on dialysis. Ardelyx has established strategic partnerships for international commercialization, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China. As a publicly traded company on NASDAQ under the symbol ARDX, Ardelyx employs approximately 201-500 professionals and continues to advance its pipeline of gastrointestinal and renal disease therapeutics.