Director, Global Quality Systems and Compliance

Scholar Rock is seeking an experienced and motivated Director of Quality Systems and GxP Compliance. Reporting to the Senior Director, Global Quality Systems and Compliance, this position will oversee aspects of quality systems and regulatory compliance across commercial, clinical, and development activities.

Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.

Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.

Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.

Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.

Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.

Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.

Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.

Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.

Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections.

BS/MS degree in a scientific discipline.

10-15 years of experience in the pharmaceutical/biotech industry, with 5+ 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.

Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.

Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.

Hands-on experience with systems such as Veeva Vault is preferred.

Highly proactive, decisive, and capable of independently managing key initiatives.