Global Head of Clinical Quality Assurance

Scholar Rock, Inc.; Cambridge (MA); On-site; USD 270,000 - 300,000; Full time

Job summary

Scholar Rock is seeking an experienced Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for GCP quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this role drives clinical quality strategy, risk management, audit oversight, and inspection readiness in a fast-paced outsourced biotech model.

The candidate will lead the Clinical QA function, partner across Clinical Operations, Regulatory

Qualifications

• BS/MS in scientific/healthcare field; advanced degree preferred.
• 15+ years in pharma/biotech with QA/GCP roles.
• 10+ years leading global GCP quality programs.
• Deep knowledge of ICH-GCP, FDA/EMA/PMDA regulations.
• Experience with biologics and inspection readiness.

Responsibilities

• Lead Clinical Quality Assurance for GCP across trials.
• Partner with Clinical Operations, Regulatory, Pharmacovigilance, and vendors.
• Define and mature clinical quality strategy and governance.
• Oversee trial documentation, data integrity, and safety reporting interfaces.
• Lead audit programs for sites, CROs, vendors, and TMF processes.
• Prepare and support FDA/EMA/PMDA inspections and responses.
• Manage CAPAs and quality issues with root-cause analysis.
• Develop quality metrics and dashboards for executive visibility.
• Mentor and grow a fit-for-purpose Clinical QA team.

Skills

Leadership

Quality systems

GCP quality

CRO oversight

Data integrity

Regulatory knowledge

Audit management

Investigator site oversight

SOPs & CAPA

Vendor management

Education

BS/MS in science or healthcare

Advanced degree preferred

Tools

TMF quality

Quality metrics dashboards

Job description

Scholar Rock is seeking an experienced Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for GCP quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this role drives clinical quality strategy, risk management, audit oversight, and inspection readiness in a fast-paced outsourced biotech model.

The candidate will lead the Clinical QA function, partner across Clinical Operations, Regulatory