Director/Sr. Director, Quality Systems and GxP Compliance

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.