Senior Director, R&D Quality

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

About Palvella

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 microcystic 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.

The Opportunity

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

Key Responsibilities

Clinical Quality Oversight (GCP)—Primary Focus

• 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 escalate 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.

BIMO & Inspection Readiness and Management—Critical Priority

• 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., EMA), managing inspection logistics, front/backroom operations, and the coordination of timely, well-controlled responses to observations.
• Build the internal capability and training so the organization remains inspection-ready on an ongoing basis, not only at submission.

Pharmacovigilance Quality Oversight (GVP)

• Provide quality oversight of pharmacovigilance activities, including AE/SAE handling, safety reporting, and oversight of PV vendors and safety data exchange.
• Ensure PV quality systems, including audit coverage and inspection readiness, support compliant safety surveillance across clinical and expanded access settings.

Nonclinical Quality Oversight (GLP)

• Provide GLP quality oversight of nonclinical and toxicology studies and the CROs conducting them, ensuring data integrity and compliance to support regulatory submissions.

R&D Quality Systems & QMS Build-Out

• Design, build, and mature Palvella’s R&D quality management system — procedural document hierarchy, SOPs/WIs, document control, and templates — appropriate to a lean organization that conducts clinical studies in-house while relying on outsourced manufacturing, testing, and distribution partners.
• Establish and own R&D quality processes including deviation/CAPA management, quality risk management, and quality metrics, reporting, and escalation.
• Develop and lead GxP and inspection-readiness training and learning management programs that ensure consistent, compliant, audit-ready organization.
• Drive continuous improvement, identifying and leading process improvement initiatives across the R&D quality landscape.
• Partner with VP QA & QC to design, build, and implement a best-in-class, fit-for-size, life-cycle quality system capable of supporting a robust pipeline and strong commercial presence.

Audit & Submission Readiness

• Establish and execute a risk-based audit program covering CROs, PV, GLP, and other R&D vendors, prioritized by NDA and BIMO impact.
• Support quality deliverables for Palvella’s first NDA submission and ensure R&D quality systems and records withstand pre-approval and BIMO inspection scrutiny.

Quality Leadership & Strategy

• Serve as a member of the quality leadership team, helping set strategic direction for quality objectives and influencing how quality operates across the company.
• Partner cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, and external partners to advance compliant, efficient operations.
• Build, mentor, and develop quality staff as the function scales.

Qualifications

Required

• Bachelor’s degree in life sciences or related discipline; equivalent professional experience will be considered.
• 15+ years of progressive experience in pharmaceutical/biotech quality, with significant depth in R&D and GxP quality management.
• Demonstrated leadership of GCP quality oversight of clinical trials — including sponsor-conducted, in-house clinical operations as well as oversight of CROs and vendors — with working knowledge across GVP and GLP.
• Proven record building or substantially maturing quality management systems and procedural document programs.
• Direct experience leading inspection readiness and hosting/managing FDA inspections, with direct BIMO inspection readiness and/or management experience strongly preferred.
• Strong command of quality risk management, root cause analysis, and CAPA/deviation processes.
• Excellent leadership, cross-functional influence, and written and verbal communication skills.

Preferred

• Experience providing quality oversight of sponsor-conducted (in-house) clinical operations, in addition to vendor/CRO oversight, in a lean clinical-stage organization.
• Direct experience supporting an NDA/MAA submission and leading BIMO and pre-approval inspection readiness through to a successful inspection outcome.
• Experience with expanded access / compassionate use programs.
• Lean Six Sigma or comparable process-improvement certification.
• Appetite to broaden into GMP/CMC and commercial quality as part of a defined growth path.

What We Offer

• A clearly defined succession path to broader enterprise quality leadership.
• The chance to build, not just maintain — meaningful ownership in a high-impact, lean organization.
• Direct, leading involvement in a company’s first NDA and BIMO inspection — a career-defining milestone.
• A mission with real human stake: first-in-class therapies for patients with rare diseases and few or no options.
• A collaborative, expert team based near Philadelphia’s life sciences corridor.

Palvella Therapeutics is an equal opportunity employer.