Lead the global GxP Quality function, ensuring regulatory compliance, operational excellence, and integration of Quality across commercial and clinical operations.
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.
Top Skills
GCP
Gdp
Glp
Gmp
Quality Control
Quality Systems
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
Similar Jobs
Machine Learning • Security • Software • Analytics • Defense
Manage the entire procurement lifecycle, ensuring compliance with federal regulations, while optimizing procurement processes and collaborating with stakeholders.
Top Skills:
Defense Federal Acquisition Regulations (Dfars)Federal Acquisition Regulations (Far)
Beauty • Robotics • Design • Appliances • Manufacturing
The Executive Assistant supports Finance executives by managing schedules, planning meetings, coordinating travel, and handling administrative tasks with a high level of discretion.
Top Skills:
ExcelMicrosoft WordOutlookPowerPointTeams
Beauty • Robotics • Design • Appliances • Manufacturing
The Associate Manager supports strategic initiatives and operational processes, coordinating between teams to ensure effective execution and alignment across commercial operations.
Top Skills:
ExcelMicrosoft Powerpoint
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
