Director, Development & Pharmacovigilance Quality

Ardelyx, Inc.; Waltham (MA); Hybrid; USD 210,000 - 260,000; Full time

Benefits offered by this job

401(k) plan with employer match

Paid parental leave (12 weeks)

Equity incentive plans

Health plans (medical, prescription, -

Job summary

Ardelyx, Inc. seeks aDirector, Development and Safety Quality to provide independent quality oversight for clinical development, nonclinical, and pharmacovigilance activities.

You will drive GCP/GLP/GVP compliance, lead quality investigations, and maintain robust quality systems from Waltham, MA with hybrid on-site presence. The role partners with Clinical Development, Drug Safety and Regulatory Affairs to ensure inspection readiness, risk management, and continuous improvement across

Qualifications

• Strong PV quality knowledge with exposure to GCP, GLP and global PV regulations.
• Experience conducting risk-based audits and supporting regulatory inspections.
• Proven ability to lead quality investigations, CAPAs, and cross-functional collaborations.

Responsibilities

• Provide quality guidance to development and drug safety teams on compliance requirements and process improvements.
• Oversee quality events, investigations and CAPAs with timely resolution and effectiveness.
• Lead inspection readiness activities and support regulatory inspections and responses.

Skills

PV Quality

GCP/GVP knowledge

Audit leadership

Risk-based decisions

Education

Bachelor's degree in science

Tools

Quality systems

Job description

Ardelyx, Inc. seeks aDirector, Development and Safety Quality to provide independent quality oversight for clinical development, nonclinical, and pharmacovigilance activities.

You will drive GCP/GLP/GVP compliance, lead quality investigations, and maintain robust quality systems from Waltham, MA with hybrid on-site presence. The role partners with Clinical Development, Drug Safety and Regulatory Affairs to ensure inspection readiness, risk management, and continuous improvement across