Head of Global GxP Quality
Scholar RockCambridge, Massachusetts, United States
Posted May 16, 2025
Full Time
About the Company
Scholar Rock is a biopharmaceutical company specializing in discovering and developing innovative therapies for serious diseases with high unmet needs. Focused on the biology of transforming growth factor beta (TGFβ) superfamily proteins, Scholar Rock has created a pipeline targeting neuromuscular disease, cardiometabolic disorders, cancer, and other conditions. The company is distinguished by its proprietary platform that develops novel monoclonal antibodies for precise protein growth factor modulation, offering transformative treatments like muscle-targeted therapies for spinal muscular atrophy (SMA).
Job Description
Scholar Rock is seeking a strategic and execution-oriented Head of Global GxP Quality to lead the Quality organization across clinical and commercial operations, encompassing GMP, GDP, GCP, GLP, Quality Systems, Quality Control, EU Quality, and post-market surveillance. The company is a global leader in TGFβ-targeted therapies and is advancing innovative treatments for neuromuscular disease, cardiometabolic disorders, and cancer. This is a mission-critical leadership role with the opportunity to shape a global Quality function.
Requirements
- 15+ years of progressive leadership in biopharmaceutical Quality
- Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems
- Successful track record of leading organizations through regulatory inspections
- Experience managing external partners (CDMOs, CROs, testing labs)
- Strong understanding of global post-market quality systems
- Proven ability to scale Quality organizations
- Excellent communication and leadership skills
- Bachelor’s degree in life sciences or related field
