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 seeking an experienced and motivated Director of Quality Systems and GxP Compliance. Reporting to the Head of Quality, this position will oversee all aspects of quality systems and regulatory compliance across commercial, clinical, and development activities. The Director will lead the implementation and maintenance of an effective Quality Management System (QMS) to ensure compliance with global regulatory requirements.
Position Responsibilities
Serve as the Quality Lead for systems and compliance operations across the organization.Provide strategic guidance to the quality function on Quality Systems and GxP compliance.Oversee and manage GxP training, document control, and QMS operations—including change controls, deviations, CAPAs, complaints, audits, and supplier management activities.Monitor the lifecycle of quality system records to preserve the integrity and compliance of Scholar Rock’s QMS.Manage the intake and triage of product complaints, ensure accurate documentation, timely escalation, and alignment across systems and departments.Assign and manage GxP training in the learning management system, track compliance, and generate completion reports as needed.Participate in validation efforts for new or updated GxP IT systems, including documentation review, test script execution, and change control support.Oversee the supplier management program, including supplier evaluations and audits.Provide metrics and reports on QMS and supplier performance during periodic quality reviews.Lead and implement Scholar Rock’s internal audit program.Drive continuous improvement initiatives to maintain compliance and enhance QMS efficiency.Support inspection readiness activities.Contribute to regulatory submissions such as annual reports, IND/CTA updates, and marketing authorizations.Lead and manage the Quality Systems and Compliance team, including direct reports.Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).
Candidate Requirements
BS/MS degree in a scientific discipline.15+ years of experience in the pharmaceutical/biotech industry, with 10+ years in leadership roles within Quality or related functions. Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.Experience leading regulatory inspections and interfacing with global health authorities.Strong knowledge of electronic Quality Management Systems, Document Management Systems, and Learning Management Systems.Hands-on experience with systems such as Veeva Vault is preferred.Highly proactive, decisive, and capable of independently managing key initiatives.Engaged people manager committed to building culture as well as mentorship and talent development.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
