Director, Development and Safety Quality

About the role

Ardelyx, a commercial-stage biopharmaceutical company, is hiring a Director, Development and Safety Quality in Waltham, Massachusetts. The role provides independent quality oversight of clinical development, nonclinical and pharmacovigilance activities for investigational and marketed products, with a focus on pharmacovigilance and drug safety quality. It works closely with Clinical Development, Clinical Operations, Nonclinical Development, Drug Safety, Regulatory Affairs and external partners to maintain quality systems, prepare for inspections and address compliance risks. The position is hybrid, with 2-3 days per week on site.

Key responsibilities

• Guide development and drug safety teams on compliance requirements, risk assessments and process improvements
• Oversee quality events, investigations and CAPAs, ensuring timely resolution
• Lead inspection readiness activities and support regulatory inspections, responses and remediation
• Develop and maintain quality policies and SOPs, and review key development and safety documents
• Support vendor and partner qualification, including quality and safety data exchange agreements, and oversee their quality and safety
• Support risk-based audits, including the PV quality audit program, and monitor quality metrics and emerging risks
• Lead training and continuous improvement, and mentor staff, auditors and consultants while supporting resource and budget planning

Required profile

• Bachelor's degree in a scientific discipline or related field
• 12+ years of pharmaceutical or biotechnology experience, including at least 5 years in GCP, GLP or PV Quality, or equivalent
• Demonstrated experience with risk-based audits, regulatory inspections, quality investigations, CAPAs, quality metrics and vendor oversight
• Proven ability to lead cross-functional initiatives, influence stakeholders and manage competing priorities
• Ability to travel domestically and internationally up to 20%

Required skills

• PV Quality and drug safety compliance, with working knowledge of GCP, GLP and global regulations
• Quality systems, computerized system validation, data integrity and electronic records
• Strong written, verbal and presentation skills

What we offer

• Anticipated annualized base pay of $210,000-$260,000, possibly with an annual bonus target and equity awards
• 401(k) with employer match, 12 weeks of paid parental leave and up to 12 weeks of living organ and bone marrow leave
• Health, dental, vision, life insurance and disability coverage, equity incentive plans, flexible time off, winter holiday shut down and at least 11 paid holidays