Avalyn Pharma is looking to solve the problem of developing innovative, targeted inhaled therapies for rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), by ensuring compliance with global cGMP requirements and delivering high-quality products.
Requirements
- 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.
- Experience with Quality Management System (QMS) development, implementation, and continuous improvement.
- Knowledge of global regulatory requirements, including FDA, EMA, and PMDA.
- Experience with cGMP requirements for clinical trial materials.
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.
Other
- Bachelor's or Master's degree in Life Science, Engineering, or related scientific field.
- Excellent oral and written communication skills, with ability to influence and collaborate effectively across functions and with external partners.
- Ability to work in a fast-paced, virtual biotech environment.
- Strong leadership and mentoring skills, with ability to mentor junior staff and provide training across Avalyn.
- Ability to collaborate effectively with internal cross-functional teams and external partners.
