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:
Position Responsibilities
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 serialization/traceability requirements and robust product security controls, as needed by market.
Candidate Requirements
BS/BA degree in a scientific or engineering discipline required; advanced degree preferred
15+ years of progressive Quality experience in biotech/pharma (biologics preferred), including significant leadership of commercial quality and oversight of external manufacturing, packaging/labeling, testing, and distribution networks; people leadership strongly preferred
Demonstrated expertise with marketed product quality systems, including commercial batch release/market disposition, product status control, complaint handling, and quality risk management
Strong working knowledge of European and Swissmedic regulations and guidance applicable to commercial supply; experience representing Quality in health authority inspections (e.g., EMA member state authorities, MHRA, Swissmedic, FDA)
Hands-on experience operating within an EU/EEA commercial release model, including governance of QP certification activities and batch certification packages; prior direct QP qualification is a plus
Experience establishing and governing post-market product monitoring, including complaint trending and signal detection interfaces with Pharmacovigilance/Medical, management review/KPIs, and continuous improvement
Proven experience leading recalls/field actions, including decision-making, health authority notifications support, cross-functional execution, and effectiveness checks; experience conducting mock recalls preferred
Demonstrated ability to lead through influence in a matrixed organization and drive effective governance across external partners (e.g., quality agreements, release expectations, GDP oversight, metrics/KPIs, escalation pathways, and performance improvement)
Strong executive presence and communication skills, sound risk-based judgment, and the ability to balance strategic leadership with timely, compliant quality decision-making
Highly proactive, decisive, and capable of independently driving complex cross-functional initiatives in a fast-paced environment; experience scaling commercial quality capabilities for European launch and expansion (including GDP networks and QP release models) and broader ex-U.S./ROW expansion strongly preferred
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.