Sr. Director, Commercial Quality​/Market Quality

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.

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.

• Provide senior leadership for Commercial Quality, ensuring patient-focused, compliant, and robust oversight of marketed product(s) and launch readiness for new indications/markets.
• Establish and own the Market Release Authorization vertical, distinguishing manufacturing batch disposition from commercial/market disposition and ensuring release decisions meet applicable market requirements (U.S., EU, and other regions as expanded).
• Serve as the end-to-end Quality leader for commercial operations, partnering with Supply Chain, Distribution/Logistics, Labeling, Regulatory, Pharmacovigilance, Medical Affairs, and Manufacturing/CMOs to enable reliable supply and compliant market execution.
• Hold decision rights to place and lift commercial holds, including for safety signals, distribution excursions, labeling issues, complaint trends, shortage mitigation, or recall-related actions; ensure clear governance, escalation pathways, and documentation.
• Own and continuously improve the post-market quality system to meet health authority expectations as per applicable guidance, and to support global regulatory commitments.
• Lead commercial product release/disposition governance, including product status control, release documentation, country-specific requirements, and oversight of release by Qualified Person (QP) (as applicable), governance of batch certification packages and escalation pathways for quality decisions.
• Provide Quality oversight for distribution and logistics, including EU GDP expectations, temperature-controlled/cold chain processes, lane qualification, distribution excursions/investigations, returns/destruction, and oversight of 3PLs and other service providers across Switzerland, EU/EEA, and other regions through quality agreements and metrics.
• Lead commercial Quality inspection readiness and external interactions, including health authority inspections, ensuring sustained compliance across the commercial supply chain.
• Lead and execute recall and field action readiness and response (including mock recalls), partnering with PV/Medical/Regulatory and Supply Chain to ensure timely decisions, effective communications, and compliant execution (including EU/UK-style Field Safety Corrective Actions where applicable).
• Oversee quality impact assessment and decision-making for changes that may affect marketed product (process, analytical, specifications, site/supplier, packaging/labeling, distribution lanes), ensuring alignment with filings/commitments and market release requirements.
• Provide governance for commercial packaging and labeling quality (artwork/label content controls, printed component release, reconciliation, tamper evidence), and partner with Regulatory Labeling to ensure compliant implementation across markets.
• Partner with Supply Chain/IT and external providers to ensure compliance with applicable…