Head of Global GxP Quality

Position Responsibilities:

• Strategic Leadership:
• Develop and execute Scholar Rock’s global GxP Quality strategy across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH).
• Serve as the executive Quality representative for regulatory inspections (e.g., FDA PAI, EMA MAA) and major health authority interactions.
• Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes.
• Quality Functional Oversight:
• GMP Quality Assurance: Oversee DS, DP, and finished goods quality across internal operations and external CDMOs; ensure compliant batch disposition and vendor oversight.
• R&D Quality (GCP/GLP): Lead quality oversight across Scholar Rock’s clinical and nonclinical development programs. This includes GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies.
• EU Quality & QP Oversight: Ensure compliance with EU GDP/importation requirements and maintain oversight of QP batch certification and market release processes.
• Quality Control (QC): Provide strategic oversight for release and stability testing, method validation/transfer, reference standards, and specification lifecycle management.
• Quality Management Systems (QMS): Own and evolve the global QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs.
• Post-Market Surveillance: Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post-market reporting requirements.
• Team Leadership & Governance:
• Build and lead a high-performing global Quality organization, ensuring technical excellence, regulatory compliance, and a culture of accountability and transparency.
• Define and monitor Quality performance metrics, implement continuous improvement initiatives, and ensure systems readiness for global scale.
• Represent Quality in executive governance forums, regulatory planning, and launch readiness reviews.

Candidate Requirements:

• 15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global commercial launches and late-stage clinical development.
• Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems, with a track record of successfully leading organizations through regulatory inspections (FDA, EMA, etc.).
• Demonstrated success managing external partners (CDMOs, CROs, testing labs) in a virtual or hybrid operating model.
• Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting.
• Proven ability to scale Quality organizations and systems to support commercial expansion and global operations.
• Excellent communication, leadership presence, and cross-functional collaboration skills.
• Bachelor’s degree in life sciences or related field required; advanced degree preferred.