Job Description
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 Senior Manager, Quality Assurance (QA) Operations is responsible for the development, implementation, and continuous improvement of Avalyn's Quality Management System (QMS), ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Pharmacovigilance Practices (GVP). This role plays a critical part in maintaining a phase-appropriate, inspection-ready state, overseeing quality systems, vendor management, and auditing functions to support Avalyn's operational and regulatory objectives. A key focus of this role includes vendor qualification, oversight, and auditing, ensuring that external partners and contract service providers adhere to regulatory requirements, industry standards, and Avalyn's internal quality expectations. Additionally, this position will play a key role in inspection readiness, ensuring Avalyn's quality systems and vendor oversight are compliant and defensible.
Beyond vendor management and auditing, this role is also responsible for electronic quality system implementation and integration, ensuring that Avalyn's quality processes are scalable, fit-for-purpose, efficient, and well-connected across departments. This individual will work cross-functionally with key functional stakeholders to drive process optimization, risk mitigation, and continuous improvement initiatives that align with Avalyn's strategic goals. In our small biotech environment, you'll have the opportunity to directly influence key decisions, helping us achieve our mission of delivering life-changing therapies for patients with unmet needs. This position will report into the VP, Quality Assurance and can be based remotely within the US.
Key Responsibilities:
* Lead the vendor qualification and oversight program, ensuring all external partners are compliant with regulatory requirements and internal quality standards.
* Oversee the approved supplier list, manage the annual audit schedule (internal and external), and lead the development and maintenance of Quality Agreements with GMP suppliers.
* Monitor supplier performance through scorecards and quality metrics, ensuring the identification and mitigation of risks while promoting compliance across the supply chain.
* Manage GXP document management and training via the Dot Compliance platform.
* Monitor global audit trends and work with internal teams to inform them of emerging areas of risk and regulations for incorporation into audit planning, vendor management and execution.
* Collaborate with internal teams and external vendors to ensure project objectives are met in a compliant and timely manner while providing GXP and QA expertise.
* Lead initiatives to promote and maintain a quality culture with a focus on Data Integrity and Good Documentation Practices.
* Partner with Avalyn's Clinical, CMC, and non-clinical teams, as well as external vendors and investigator sites, to provide GXP QA oversight and develop risk assessments and quality oversight initiatives.
* Provide QA review and approval for Drug Substance and Drug Product specifications, batch records, and product complaints, as needed.
* Ensure appropriate and timely escalation of quality events (e.g., potential misconduct or significant deviations, quality issues at external vendors, etc.) to leadership.
* Oversee GXP inspection readiness activities, partnering with internal operational and Quality leadership.
* Develop and monitor quality performance indicators to assess and drive continuous improvement within the quality system.
* Contribute to Quality Management Review processes while ensuring compliance with regulatory requirements and industry standards (e.g., FDA, EMA, cGMP).
Key Requirements for this role are:
* Bachelor's degree in science, public health, psychology, sociology, or a related field with 6+ years of biotech or pharmaceutical industry experience required.
* In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
* Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems.
* Creative thinker and subject matter expert in pharmaceutical quality systems with the ability to design and implement a 'fit for purpose' Quality Management System and a passion for driving a quality mindset across the organization.
* Experience conducting and managing internal and external GXP audits.
* Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management, change control, corrective action preventative action, and deviation management processes.
* Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance.
* Proven ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively.
* Experience working cross-functionally with internal stakeholders including clinical development teams and CMC.
Proposed pay range: $150,000—$170,000 USD
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