Senior Director, Global Quality Systems and Compliance

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.