Director, Product Quality chez Avalyn Pharma

Company Overview:

Avalyn Pharma is developing innovative, targeted inhaled therapies for rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C financing in September 2023 to advance our clinical-stage pulmonary fibrosis portfolio consisting of inhaled pirfenidone (AP01), inhaled nintedanib (AP02), and a fixed-dose combination of both (AP03). Currently, treatment for IPF and PPF includes oral antifibrotics, pirfenidone and nintedanib. Due to side effects, 30-50% of patients cannot tolerate these medications. Avalyn has developed inhaled formulations for these FDA-approved antifibrotics. AP01 has now been studied in over 150 patients with various forms of pulmonary fibrosis, over at least 48 weeks and some out to 4 years and is phase 2b ready. PK studies show that AP01 reaches thirty-five times the concentration in the lung with 1/15th of the systemic concentration compared to historic oral pirfenidone. AP01 has demonstrated efficacy, with a high dose achieving near stabilization of lung function and is well tolerated with fewer systemic adverse events vs. historic oral pirfenidone. We have also completed our a phase 1a study of AP02, an inhaled formulation of nintedanib, with phase 1b & 2 plans being developed. Phase 1a positive topline results were announced in March 2023, and AP02 was demonstrated to be safe and well tolerated in normal volunteers & IPF patients.

Position Overview:

The Director, Product Quality will play a critical role in Avalyn Pharma’s success by providing QA leadership and oversight of CMC operations across Avalyn and its global network of CDMOs, CMOs, and suppliers. Reporting to the Vice President, Quality Assurance, this role will ensure that Avalyn’s drug substance, drug product, and combination product manufacturing activities are conducted in compliance with global cGMP requirements and aligned with Avalyn’s mission to deliver innovative inhaled therapies for rare respiratory diseases. The Director will contribute to strategic planning, risk management, and continuous improvement initiatives while ensuring inspection readiness and maintaining a culture of quality and compliance. This role requires strong operational experience, the ability to work in a fast-paced, virtual biotech environment, and the skills to collaborate effectively with internal cross-functional teams and external partners. 

Key Responsibilities:

• Provide quality leadership for clinical-stage product manufacturing, testing, packaging, and labeling to ensure compliance with cGMPs, global regulatory expectations, and Avalyn’s internal quality standards.
• Act as the primary Quality point of contact for Avalyn’s CDMOs/CMOs and external testing and packaging partners; oversee day-to-day quality interactions and maintain strong partnerships.
• Make key decisions on product quality, compliance, and regulatory conformance issues for investigational products, escalating significant risks to Avalyn senior leadership.
• Review and approve quality-critical documentation, including protocols, reports, master batch records, executed batch records, and release documentation.
• Ensure that Quality and Technical Agreements are aligned with contractual obligations and are being fulfilled by Avalyn and its external partners.
• Provide QA oversight for deviations, CAPAs, change controls, and OOS investigations, ensuring Avalyn participates in planning and agreement of investigation strategies for critical and major events.
• Lead or oversee inspection readiness activities with Avalyn’s external partners to support FDA, EMA, PMDA, and other global health authority inspections related to clinical trial manufacturing.
• Support regulatory submissions by contributing to or reviewing quality-related sections of INDs, CTAs, and Annual Reports; participate in responses to regulatory authority questions as needed.
• Lead the collection, review, and communication of quality metrics for management review, linking compliance performance with clinical program execution and continuous improvement initiatives.
• Partner with Regulatory, CMC, Clinical Operations, and Supply Chain functions to ensure alignment of quality and compliance requirements across Avalyn’s global development programs.
• Contribute to Avalyn’s Quality Management System (QMS) by developing, implementing, and continuously improving global SOPs, training programs, and systems that support clinical trial manufacturing.
• Mentor junior staff and provide training across Avalyn to promote a strong culture of quality, patient safety, and compliance.

Key requirements for this role are:

• Bachelor’s or Master’s degree in Life Science, Engineering, or related scientific field. 
• Minimum of 10 years of GxP experience in biopharmaceutical or biotechnology industries with strong focus on Quality Assurance and cGMP for clinical trial materials. 
• At least 5 years in roles of increasing leadership responsibility providing QA oversight of external manufacturing, testing, and packaging partners. 
• Experience supporting investigational product manufacturing for Phase 1–3 clinical trials; rare disease and/or combination product experience preferred. 
• Strong knowledge of quality systems, deviation/investigation management, risk assessment, and regulatory compliance expectations. 
• Excellent oral and written communication skills, with ability to influence and collaborate effectively across functions and with external partners. 
• Experience in a small, fast-paced, entrepreneurial biotech environment preferred.