Job Description
Job Description
Company Overview:
Company Overview:
Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 1b study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn.
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.
Proposed pay range$210,000—$228,000 USD