Global Quality Control Director - Commercial Readiness

Scholarrock; Cambridge (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Scholar Rock is seeking an experienced Director of Global Quality Control to support commercial readiness and ongoing QC operations. Reporting to the Sr.

Dir Product Quality, this role leads the commercial QC function across an outsourced network, ensuring inspection readiness and compliance for global markets. You will oversee release, stability, specification lifecycle, and external laboratory oversight, partnering with Manufacturing, Regulatory, Analytical Development, and QA to enable

Qualifications

• BS/MS in a scientific discipline; advanced degree preferred.
• 10+ years in Quality Control and/or Analytical Sciences in biotech/pharma.
• Experience supporting commercial GMP products and outsourced operating models.
• Strong knowledge of USP, EP, JP, cGMP, ICH and data integrity.
• Experience with stability programs and post-approval changes.
• Ability to lead in a matrixed organization and manage external relationships.
• Excellent communication and collaboration skills.

Responsibilities

• Lead and manage commercial QC across outsourced labs and CMOs.
• Oversee commercial stability programs and protocol governance.
• Manage specification lifecycle and post-approval revisions.
• Support commercial lot release and regulatory commitments.
• Ensure inspection readiness and data integrity.

Skills

Quality Control leadership

Analytical Sciences

Cross-functional collaboration

Communication skills

Data integrity

Matrix leadership

Education

BS/MS in a scientific discipline

Tools

Contract testing laboratory oversight

Outsourced partner management

Job description

Scholar Rock is seeking an experienced Director of Global Quality Control to support commercial readiness and ongoing QC operations. Reporting to the Sr.

Dir Product Quality, this role leads the commercial QC function across an outsourced network, ensuring inspection readiness and compliance for global markets. You will oversee release, stability, specification lifecycle, and external laboratory oversight, partnering with Manufacturing, Regulatory, Analytical Development, and QA to enable