Director/Sr. Director, Quality Systems and GxP Compliance

Role Summary

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.

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‚Äîincluding 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‚Äôs 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‚Äôs 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).

Qualifications

• BS/MS degree in a scientific discipline
• 10+ years of experience in the pharmaceutical/biotech industry, with 5‚Äì7 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

Education

• BS/MS degree in a scientific discipline