Senior Director, GCP Quality Assurance

<div class="content-intro"><p><span style="text-decoration: underline;"><strong>About Beeline Medicines:</strong></span></p> <p>Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully.</p></div><p><span style="text-decoration: underline;"><strong>Job Summary:</strong></span></p> <p>The Senior Director, GCP Quality Assurance provides strategic leadership and operational oversight for Good Clinical Practice (GCP) Quality Assurance activities supporting the company’s clinical development programs. This role is accountable for ensuring that clinical trials are conducted, documented, and reported in compliance with applicable regulatory requirements, company policies, and global GCP standards while maintaining a continuous state of inspection readiness.</p> <p>The Senior Director serves as a senior QA leader and strategic partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, and external service providers. The role is accountable for GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose GCP processes that embed quality by design across the clinical lifecycle.</p> <p><span style="text-decoration: underline;"><strong><br>Work Arrangement &amp; Location:&nbsp;</strong></span></p> <p><strong>Hybrid - </strong>This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as <strong>Tuesday and Wednesday</strong>. Additional on-site days may be required based on business needs, team priorities, or leadership direction.</p> <p><span style="text-decoration: underline;"><strong><br>Essential Duties and Responsibilities: </strong></span></p> <ul> <li>Define, implement, and continuously mature the GCP QA strategy aligned with clinical development objectives, corporate priorities, and global r