Head of Global GxP Quality

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Summary of Position: Scholar Rock is entering a transformative phase with its first global commercial launch underway and a pipeline of biologics advancing through clinical development. We are seeking a strategic, execution-oriented Head of Global GxP Quality to lead our Quality organization across both commercial and clinical operations. Reporting to the Chief Technical & Quality Officer (CTO/CQO), this role will be accountable for building and leading a global, integrated GxP Quality function, spanning GMP, GDP, GCP, GLP, Quality Systems, Quality Control, EU Quality, and post-market surveillance. Position Responsibilities: Strategic Leadership: Develop and execute Scholar Rock’s global GxP Quality strategy across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH). Serve as the executive Quality representative for regulatory inspections (e.g., FDA PAI, EMA MAA) and major health authority interactions. Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes. Quality Functional Oversight: GMP Quality Assurance, R&D Quality (GCP/GLP), EU Quality & QP Oversight, Quality Control (QC), Quality Management Systems (QMS), and Post-Market Surveillance. Team Leadership & Governance: Build and lead a high-performing global Quality organization, ensuring technical excellence, regulatory compliance, and a culture of accountability and transparency. Candidate Requirements: 15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global commercial launches and late-stage clinical development. Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems, with a track record of successfully leading organizations through regulatory inspections (FDA, EMA, etc.). Demonstrated success managing external partners (CDMOs, CROs, testing labs) in a virtual or hybrid operating model. Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting. Proven ability to scale Quality organizations and systems to support commercial expansion and global operations. Excellent communication, leadership presence, and cross-functional collaboration skills. Bachelor’s degree in life sciences or related field required; advanced degree preferred. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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