Director, Development and Safety Quality
About The Position
The Director, Development and Safety Quality provides independent quality oversight of clinical development, nonclinical, and pharmacovigilance activities for Ardelyx’s investigational and marketed products. The role supports compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practices (GVP), with particular emphasis on pharmacovigilance and drug safety quality. The Director partners with Clinical Development, Clinical Operations, Nonclinical Development, Drug Safety, Regulatory Affairs, and external partners to maintain effective quality systems, support inspection readiness, and address compliance risks. The position combines functional leadership with hands-on work across audits, quality investigations, corrective and preventive actions, and continuous improvement. It is a hybrid role based out of Ardelyx’s Waltham, Massachusetts office, requiring on-site presence two to three days per week.
Requirements
- Bachelor’s degree in a scientific discipline or related field with 12 or more years of relevant pharmaceutical or biotechnology experience, including at least five 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%.
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 standard operating procedures (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 vendors 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 overseeing 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.
Benefits
- 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 covering medical, prescription drugs, dental, and vision
- Life insurance and disability coverage
- Flexible time off
- Annual Winter Holiday shutdown
- At least 11 paid holidays
- Compensation package may include an annual bonus target and equity awards, subject to eligibility and other requirements
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What This Job Offers
Job Type
Full-time
Career Level
Director
