Senior Director, R&D Quality

Department:Quality Assurance & Quality Control
Company:Palvella Therapeutics
Location:Wayne, PA
Reports To:Vice President, Quality Assurance & Quality Control

Palvella Therapeutics is a clinical-stage biopharmaceutical company on a mission to develop and deliver the first FDA-approved therapies for serious, rare genetic skin diseases that have long been overlooked. Our lead program, QTORIN™ rapamycin (PTX-022), has earned Breakthrough Therapy, Orphan Drug, and Fast Track designations. With the Phase 3 SELVA trial in micro cystic lymphatic malformations now complete, we are actively preparing our first New Drug Application submission — and the pre-approval and BIMO inspections that come with it.

We operate a lean, focused model while directing a network of best-in-class partners across manufacturing, testing, and distribution. That structure means real ownership, broad scope, and the rare chance to build quality infrastructure from the ground up rather than inherit it — and to see the direct line between your work and a therapy reaching patients who have had no other options.

This is a build-and-lead role for a senior quality professional who wants their next move to be a step up, not a step sideways. As Senior Director, R&D Quality, you will own quality oversight across Palvella’s entire research and development ecosystem — Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP) — and architect the R&D quality systems that will carry the company through its first NDA submission and BIMO inspection and into commercialization.

With our pivotal trial complete and the NDA in active preparation, you will join at a defining inflection point and play a leading role in making Palvella inspection ready.

The role is structured intentionally as a succession path. You will partner closely with the VP, QA & QC, leading the R&D quality function while developing the breadth — including GMP/CMC and commercial quality readiness — to step into broader enterprise quality leadership as the company grows toward and beyond approval. If you have deep R&D quality expertise and the ambition to expand it across the full product lifecycle, this role is designed to get you there

• Lead risk-based GCP quality oversight of Palvella’s clinical program, including quality oversight of completed pivotal trial activities through database lock, study closeout, and clinical study reporting, as well as any subsequent studies, ensuring compliance with ICH-GCP, applicable regulations, and protocol.
• Provide direct GCP quality oversight of Palvella’s sponsor-conducted clinical studies, including clinical operations activities performed in-house — site selection and management, monitoring, informed consent, the trial master file, and source data and data integrity at the point of conduct.
• Provide quality oversight of CROs, central labs, and clinical vendors where engaged, ensuring effective sponsor oversight and clear, consistent quality expectations across both in-house and partner-conducted activities.
• Quality review and approval of key clinical quality documents, plans, and controlled procedures.
• Evaluate and elevate potential serious breaches, scientific misconduct, and data integrity concerns; lead root cause analysis and ensure timely, effective CAPA.
• Partner with Clinical Operations, and Regulatory Affairs to embed quality by design into study conduct and documentation.

• Own end-to-end BIMO (Bioresearch Monitoring) inspection readiness in support of the NDA, establishing and executing a BIMO readiness program that prepares Palvella’s in-house clinical operations, sponsor oversight records, CROs, clinical sites, and supporting functions for FDA inspection.
• Lead inspection-readiness assessments, mock inspections, and remediation across R&D, ensuring the trial master file, sponsor oversight documentation, and quality records are complete, accurate, and inspection-ready.
• Serve as a primary liaison and inspection host for FDA BIMO and other Health Authority inspections (e.g.,…