Director, External QA & CMC Quality Assurance

Scholar Rock, Inc.; Cambridge (MA); On-site; USD 200,000 - 260,000; Full time

Job summary

Scholar Rock seeks an experienced Director of Quality Assurance to support External and CMC Quality Assurance. You will oversee external partner governance for manufacturing, testing and release of biological products, and collaborate with CMC teams to maintain quality systems and ensure inspection readiness.

The role requires leadership in quality, risk management, and a proactive approach to drive continuous improvement across clinical and commercial programs.

Qualifications

• 5+ leader-level experience in Quality or related functions
• Strong knowledge of GMP/GxP requirements and regulatory expectations
• Experience overseeing external manufacturers and testing labs
• Experience with biologics in clinical and/or commercial stages

Responsibilities

• Provide QA oversight over Drug Substance manufacturing across multiple CMOs.
• Oversee deviations, investigations, CAPAs, change controls, testing, and disposition decisions.
• Design a robust product disposition program for clinical and commercial materials.
• Maintain inspection readiness across outsourced operations and support health authority inspections.
• Monitor partner quality performance using metrics and governance forums.
• Assess quality risk for process changes, deviations, investigations, tech transfer, and supply continuity.
• Offer strategic guidance on quality requirements for lifecycle activities including clinical and commercial supply.
• Promote a culture of quality and proactive issue identification across stakeholders and partners

Skills

GMP/GxP knowledge

Regulatory expectations

Quality leadership

Communication skills

Strategic execution

Education

BS/MS in scientific discipline

Job description

Scholar Rock seeks an experienced Director of Quality Assurance to support External and CMC Quality Assurance. You will oversee external partner governance for manufacturing, testing and release of biological products, and collaborate with CMC teams to maintain quality systems and ensure inspection readiness.

The role requires leadership in quality, risk management, and a proactive approach to drive continuous improvement across clinical and commercial programs.