Head of Global GxP Quality
Cambridge, MA
Development – Global Quality /
Full-Time /
On-site
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. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
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. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
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. This is a mission-critical leadership role responsible for ensuring regulatory compliance, global inspection readiness, and operational excellence across the product lifecycle.
Scholar Rock is advancing life-changing therapies rooted in biologics and deep science. With our first commercial product approaching launch and a pipeline of promising assets, we are building for the long term. This role offers a rare opportunity to lead and shape a global Quality function at one of the most critical and exciting moments in our growth trajectory.
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: Oversee DS, DP, and finished goods quality across internal operations and external CDMOs; ensure compliant batch disposition and vendor oversight.
- R&D Quality (GCP/GLP): Lead quality oversight across Scholar Rock’s clinical and nonclinical development programs. This includes GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies.
- EU Quality & QP Oversight: Ensure compliance with EU GDP/importation requirements and maintain oversight of QP batch certification and market release processes.
- Quality Control (QC): Provide strategic oversight for release and stability testing, method validation/transfer, reference standards, and specification lifecycle management.
- Quality Management Systems (QMS): Own and evolve the global QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs.
- Post-Market Surveillance: Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post-market reporting requirements.
- Team Leadership & Governance:
- Build and lead a high-performing global Quality organization, ensuring technical excellence, regulatory compliance, and a culture of accountability and transparency.
- Define and monitor Quality performance metrics, implement continuous improvement initiatives, and ensure systems readiness for global scale.
- Represent Quality in executive governance forums, regulatory planning, and launch readiness reviews.
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.
