Location:

Wayne, PA /

In-Person Company:

Palvella Therapeutics Position Summary:

The Associate Director, Quality Assurance plays a critical role in supporting the development, implementation, and continuous improvement of the Quality Management System (QMS) at Palvella Therapeutics. This position ensures that quality assurance activities are conducted in accordance with applicable regulatory requirements and internal quality standards, supporting the company's clinical-stage programs through potential commercialization. This role is responsible for executing and overseeing core QA functions including document control, deviation and CAPA management, internal and external audit support, and regulatory compliance activities. The Associate Director, QA will collaborate cross-functionally with Clinical Operations, Regulatory Affairs, CMC, and contract manufacturing organizations (CMOs) to maintain a state of inspection readiness and support the company's NDA submission goals. This position requires a detail-oriented quality professional with strong working knowledge of GMP/GCP regulations and hands-on experience in a clinical-stage or early commercial pharmaceutical environment. The Associate Director will work under the strategic direction of the

VP, QA/QC

while independently driving execution of quality programs and serving as a subject matter expert (SME) on QA matters.

Key Responsibilities:

Quality Management System (QMS)

Execution:

Support the development, maintenance, and continuous improvement of the company's QMS. Ensure SOPs, policies, and quality documents are current, controlled, and aligned with regulatory expectations.

Regulatory Compliance:

Ensure QA operations comply with applicable regulations and guidelines (e.g., FDA 21 CFR Parts 210/211/312, GMP, GCP, ICH). Monitor regulatory developments and assess impact on quality systems and procedures.

Document Control & Change Control:

Oversee the document control system, including the creation, review, approval, and retirement of SOPs, forms, and controlled documents. Manage change control processes to ensure changes are evaluated, documented, and implemented appropriately.

Deviation & CAPA Management:

Lead the investigation of deviations, out-of-specification (OOS) results, and quality events. Develop and track corrective and preventive actions (CAPAs) to ensure timely resolution and sustained effectiveness.

Batch Record Review & Product Release Support:

Review executed batch records, laboratory data, and associated documentation for completeness and compliance. Support disposition decisions and product release activities in collaboration with QC.

Audit & Inspection Readiness:

Conduct and support internal audits and qualify supplier/vendor audits. Assist in the preparation for and management of external regulatory inspections (e.g., FDA

PAI, BIMO

). Maintain ongoing inspection readiness posture.

Supplier & CMO Quality Oversight:

Support qualification and ongoing oversight of contract manufacturers, testing laboratories, and other external partners. Maintain quality agreements and monitor vendor performance against quality requirements.

Training Program Support:

Assist in developing and delivering GMP/GCP training programs for internal staff and external partners. Ensure training records are maintained and that personnel are current with applicable quality requirements.

Quality Metrics & Reporting:

Track and report on key quality metrics, including CAPA status, deviation trends, audit findings, and document control performance. Provide regular updates to the VP, QA/QC and contribute to quality management reviews.

NDA Submission Support:

Contribute QA expertise to the preparation of regulatory submissions, including NDA sections related to quality systems, CMC, and GMP compliance. Support compilation and review of quality data packages.

Cross-Functional Collaboration:

Partner with Regulatory Affairs, Clinical Operations, CMC, and Manufacturing to integrate quality requirements across the product development lifecycle. Serve as a quality resource and SME for cross-functional project teams.

Qualifications:

A 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 at least 2-3 years in a senior or lead QA role. Demonstrated experience supporting QA activities in a clinical-stage or commercial pharmaceutical or biopharmaceutical environment. Solid working knowledge of GMP, GCP, FDA, ICH, and applicable regulatory guidelines. Proven track record in deviation investigation, CAPA management, document control, and audit execution. Experience with rare disease or specialty pharmaceutical programs is a plus. Strong attention to detail and ability to manage multiple priorities in a fast-paced, resource-constrained environment. Excellent written and verbal communication skills, with ability to clearly articulate quality requirements and findings to cross-functional stakeholders. Analytical and critical-thinking skills, with the ability to assess risk and recommend pragmatic quality solutions. Experience with electronic quality management systems (eQMS) and document management platforms. Ability to work independently while maintaining alignment with senior leadership and organizational goals. Collaborative team player with the ability to influence without authority.

Preferred Qualifications:

An advanced degree (Master's or PhD) in a related field is preferred. Familiarity with NDA preparation, regulatory submissions, or FDA inspection support is strongly preferred. Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer) or GMP-related certifications. 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