The Director of Quality Systems and GxP Compliance ensures compliance with regulatory standards, manages the quality management system, and leads the compliance team.
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/Sr. Director of Quality Systems and GxP Compliance. Reporting to the Head of Quality, this position will oversee all aspects of quality systems and compliance for commercial, clinical, and development activities. The position is responsible for managing an effective Quality Management System to ensure continued compliance with all global regulatory requirements.
Position Responsibilities:
- Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function.
- Oversee and manage GxP Training, Document control, and QMS GxP operations—including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities.
- Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock’s Quality system.
- Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.
- Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed.
- Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
- Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings.
- Implement and oversee Scholar Rock’s internal audit program.
- Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency.
- Support inspection readiness activities, as needed.
- Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or 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
- 10+ years of experience in the pharmaceutical/biotech industry, with 5–7 years in leadership roles within Quality or Quality related functions.
- Deep understanding and current knowledge of all relevant GxP and Quality System requirements (US, EU) for pharmaceutical and biotech, manufacturing and related activities.
- Experience leading and managing regulatory inspections and interfacing with Global Health Authorities.
- Demonstrated understanding 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.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Top Skills
Document Management Systems
Quality Management Systems
Veeva Vault
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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