Director, External & CMC Quality Assurance

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

 

Scholar Rock is seeking an experienced and motivated Director of Quality Assurance to support External and CMC Quality Assurance.  This role will provide oversight of external partner (Contract Organization) governance for the manufacturing, testing, and release of biological products.  This position will work cross-functionally with the CMC teams (Manufacturing, QC, MSAT, etc) and the external partners.  This role is responsible for managing quality system records (change control, deviations, product complaints, batch disposition, etc.) and quality risk management to deliver product for clinical and/or commercial purposes.  This role will also be responsible for advancing a strong quality culture for proactive issue identification and a state of inspection readiness. This position reports to the Sr. Director, External & CMC Quality Assurance.