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Scholar Rock

Sr. Director, Commercial Quality / Market Quality

Scholar Rock
ZugPosted 4 days ago
Full-timehybrid

Job Description

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the 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 at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
 
Summary of Position:

Scholar Rock is seeking an experienced and motivated Senior Director, Commercial Quality / Market Quality (Switzerland) to build and lead a phase-appropriate, scalable, and inspection-ready Commercial Quality function as Scholar Rock advances to and expands in commercial supply. Reporting to the Head of Global Quality, this role is the Quality leader accountable for establishing clear separation between manufacturing control and commercial control through creation of a dedicated Market Release Authorization vertical, ensuring compliant disposition for each market and reliable supply to patients.

Based in Switzerland, the Senior Director, Commercial Quality is accountable for EU/EEA-aligned commercial quality governance, including oversight of QP certification and market release readiness (where applicable), and for establishing the authority to place and lift commercial holds (including for safety, distribution, shortage mitigation, and recall/field action reasons). This leader will create robust post-market controls that meet FDA, European/Swiss expectations (and ROW in market requirements) to ensure compliant product release, complaint handling, investigations/CAPA, and effective management of quality risks in the marketplace. 

Scholar Rock is seeking an experienced and motivated Senior Director, Commercial Quality / Market Quality (Switzerland) to build and lead a phase-appropriate, scalable, and inspection-ready Commercial Quality function as Scholar Rock advances to and expands in commercial supply. Reporting to the Head of Global Quality, this role is the Quality leader accountable for establishing clear separation between manufacturing control and commercial control through creation of a dedicated Market Release Authorization vertical, ensuring compliant disposition for each market and reliable supply to patients.

Based in Switzerland, the Senior Director, Commercial Quality is accountable for EU/EEA-aligned commercial quality governance, including oversight of QP certification and market release readiness (where applicable), and for establishing the authority to place and lift commercial holds (including for safety, distribution, shortage mitigation, and recall/field action reasons). This leader will create robust post-market controls that meet FDA, European/Swiss expectations (and ROW in market requirements) to ensure compliant product release, complaint handling, investigations/CAPA, and effective management of quality risks in the marketplace. 

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the 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 at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
 
Summary of Position:
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
About Scholar Rock
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Sr. Director, Commercial Quality / Market Quality at Scholar Rock | Renata