Director, Clinical Quality - Program and Process Quality
Listed on 2026-01-14
-
Quality Assurance - QA/QC
Director, Clinical Quality - Program and Process Quality
Location: United States – Remote (requires flexibility and willingness to travel as needed)
The Opportunity
Praxis is hiring a Clinical Quality leader who sees quality as a catalyst—not a checkpoint. In this role, you’ll help define and drive a strong Sized GCP quality culture across all clinical programs, balancing rigor with speed and foresight. You’ll oversee clinical quality systems and metrics, anticipate and mitigate risk before it becomes an issue, and work shoulder‑to‑shoulder with Clinical Operations, Regulatory, Safety, and other partners to keep our trials inspection‑ready and continuously improving.
You’ll also support and develop Clinical Quality team members embedded in programs, guiding inspection readiness, deviations, investigations, audits, and CAPAs—while helping shape an integrated, proactive quality strategy that scales with our pipeline.
Responsibilities- Develop and report key quality metrics across all clinical programs and trials.
- Assess current‑state quality across programs, processes and trials.
- Identify trends, risks and lead process and system improvements.
- Ensure compliance with GCP, ICH‑GCP, FDA, EMA, PMDA and applicable regulations ribbons.
- Collaboratively author standard operating procedures and related documents.
- Monitor regulatory changes and assess impact to programs.
- Provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).