Scholarrock20d ago

Director, Vendor Quality Management

United States·CambridgeFull-Timeexecutive

OperationsManagement

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OperationsManagement

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:

Lead the implementation of a global, risk-based GxP vendor oversight program aligned with industry best practices and global regulatory expectations (e.g., ICH Q9, data integrity principles, and applicable GxP requirements), ensuring scalability to support commercial operations.

Establish and operationalize an end-to-end vendor lifecycle management framework, including vendor selection, qualification, onboarding, performance monitoring, issue and CAPA management, change management, periodic review, requalification, and vendor termination activities.

Develop and implement a tiered vendor segmentation and risk methodology, defining vendor criticality classifications, risk scoring criteria, oversight requirements, and triggers for enhanced monitoring and requalification activities.

Build and mature a right-sized audit and monitoring program proportional to vendor risk and criticality, including risk-based audit planning, remote and on-site audit strategies, audit execution standards, and integration of audit outcomes into CAPA and management review processes.

Define and implement vendor oversight governance mechanisms, including KPIs, dashboards, management review processes, escalation pathways, and periodic business reviews to enable proactive performance and compliance management.

Partner cross-functionally with Quality, Supply Chain, Manufacturing, Technical Operations, Regulatory, and IT teams to ensure alignment of vendor oversight activities with business objectives and regulatory expectations.

Lead technology enablement efforts supporting vendor oversight processes, including assessment and optimization of eQMS and related systems (e.g., Veeva Vault), definition of workflows, user requirements, reporting capabilities, and configuration enhancements to support scalable execution and visibility.

Provide strategic oversight of vendor-related quality risks and compliance issues, ensuring appropriate escalation, investigation, remediation, and continuous improvement activities.

Support inspection readiness and regulatory inspections related to vendor oversight activities, ensuring vendor management processes and records are inspection-ready and aligned with global regulatory expectations.

BS/MS degree in a scientific discipline.

10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years’ experience overseeing Vendor Quality Management

Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development.

Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.

Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.

Hands-on experience with systems such as Veeva Vault is preferred.

Highly proactive, decisive, and capable of independently managing key initiatives.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.