Quality Assurance Director, External & CMC (Biologics)

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

Job summary

Scholar Rock in Cambridge, MA is seeking an experienced Director of Quality Assurance to lead External and CMC QA. This role provides governance over contract manufacturers and labs, ensuring GMP/GxP compliance and product release for clinical and commercial use.

You will partner with manufacturing, QC, MSAT and other teams to build a robust quality system and maintain inspection readiness. The ideal candidate has a BS/MS in a scientific field, 12+ years in pharma/biotech with 5+ years in

Qualifications

• BS/MS degree in a scientific discipline with extensive pharma/biotech experience.
• 12+ years in the pharmaceutical/biotech industry, 5+ in leadership within QA or related functions.
• Strong knowledge of GMP/GxP requirements, FDA/EMA expectations and ICH guidance.

Responsibilities

• Provide QA oversight over external contract manufacturing and testing operations.
• Govern deviations, investigations, CAPAs, change controls, testing and disposition decisions.
• Design robust product disposition programs for clinical and commercial material.
• Maintain inspection readiness across outsourced operations and support inspections.
• Monitor partner QA performance with metrics and governance forums.
• Assess quality risk of process changes, tech transfer and supply continuity.
• Provide strategic QA guidance across clinical and commercial lifecycle activities.

Skills

Quality leadership

GxP knowledge

Regulatory know-how

Risk management

Cross-functional collaboration

Education

BS/MS in science

Tools

GMP/GxP

FDA/EMA guidance

ICH guidance

Job description

Scholar Rock in Cambridge, MA is seeking an experienced Director of Quality Assurance to lead External and CMC QA. This role provides governance over contract manufacturers and labs, ensuring GMP/GxP compliance and product release for clinical and commercial use.

You will partner with manufacturing, QC, MSAT and other teams to build a robust quality system and maintain inspection readiness. The ideal candidate has a BS/MS in a scientific field, 12+ years in pharma/biotech with 5+ years in