Senior Associate Director, QA — Clinical Stage

Palvella Therapeutics, Inc.; Pennsylvania; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Palvella Therapeutics, Inc. is seeking an Associate Director, Quality Assurance to lead QMS development and ongoing improvement in support of clinical-stage programs and potential commercialization.

The role requires strong GMP/GCP knowledge, regulatory experience, and a track record in deviation and CAPA management within a pharmaceutical environment. This position reports to the VP, QA/QC and partners across Regulatory, Clinical Operations, and CMOs.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific field is required.
• Minimum of 7 years of experience in pharmaceutical quality assurance, with 2–3 years in a senior or lead QA role.
• Solid working knowledge of GMP, GCP, FDA, ICH, and applicable regulatory guidelines.

Responsibilities

• Support development, maintenance, and continuous improvement of the QMS.
• Ensure SOPs, policies, and quality documents are current and controlled.
• Lead deviation investigations, CAPA management, and audit support.
• Provide NDA submission support and QA SME guidance across cross-functional teams.
• Maintain inspection readiness and supplier/CMO quality oversight.

Skills

Quality Assurance

Regulatory knowledge

Cross-functional collaboration

Analytical thinking

Documentation

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field

Advanced degree preferred (Master’s or PhD)

Tools

eQMS

Document management platforms

Job description

Palvella Therapeutics, Inc. is seeking an Associate Director, Quality Assurance to lead QMS development and ongoing improvement in support of clinical-stage programs and potential commercialization.

The role requires strong GMP/GCP knowledge, regulatory experience, and a track record in deviation and CAPA management within a pharmaceutical environment. This position reports to the VP, QA/QC and partners across Regulatory, Clinical Operations, and CMOs.