Director, Global Commercial QC

Scholar Rock; Cambridge (MA); On-site; USD 200,000 - 240,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Scholar Rock seeks a Director of Global Quality Control to lead commercial QC across a fully outsourced network. You will oversee external laboratories, CMOs, and contract partners to support commercial drug substance, drug product, and stability testing, ensuring inspection readiness and regulatory compliance.

You will drive specification lifecycle management, method lifecycle activities, and post-approval stability requirements, collaborating with Regulatory Affairs and Manufacturing to

Qualifications

• BS/MS degree in a scientific discipline; advanced degree preferred.
• 10+ years in Quality Control and/or Analytical Sciences in biotech/pharma.
• Strong technical expertise in analytical methods for biologics and other modalities.
• Knowledge of USP/EP/JP, cGMP, ICH, data integrity, and release readiness.
• Experience with commercial stability programs and post-approval stability requirements.
• Experience with contract testing labs and outsourced manufacturing partners.

Responsibilities

• Lead elements of commercial QC across a fully outsourced model with external labs and CMOs.
• Oversee commercial analytical control strategy, compendial compliance, and specification lifecycle management.
• Manage commercial stability programs, data review, trending, and shelf-life commitments.
• Drive specification lifecycle activities and market-specific requirements.
• Ensure method transfer, validation maintenance, verification, and performance monitoring across labs.
• Support commercial lot release, regulatory commitments, and response to health authority inspections.
• Provide governance and leadership for a scalable, compliant QC system in a virtual biotech environment.
• Collaborate with cross-functional partners to align QC with regulatory obligations.

Skills

Quality leadership

Analytical methods

GMP knowledge

Regulatory knowledge

Communication

Education

BS/MS in scientific discipline

Advanced degree preferred

Job description

Scholar Rock seeks a Director of Global Quality Control to lead commercial QC across a fully outsourced network. You will oversee external laboratories, CMOs, and contract partners to support commercial drug substance, drug product, and stability testing, ensuring inspection readiness and regulatory compliance.

You will drive specification lifecycle management, method lifecycle activities, and post-approval stability requirements, collaborating with Regulatory Affairs and Manufacturing to