The Director of Quality Systems and Compliance will lead the transition to a scalable QMS, ensuring compliance and oversight in GxP, optimizing core processes, and handling product complaints.
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
- Support global Quality Management System (QMS) transition from clinical-stage operations to a commercial-ready, scalable, and inspection-ready environment.
- Optimize core QMS processes (change control, deviations, CAPAs, complaints, audits, document control, training, and supplier quality) to ensure they are efficient, phase-appropriate, and scalable for commercial operations.
- Establish and drive a proactive compliance framework that ensures sustained inspection readiness and supports global regulatory expectations.
- Strengthen the product complaint handling program, ensuring robust intake, triage, investigation, escalation, and trending processes that can support increased product volume and market distribution.
- Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
- Lead validation of GxP computerized systems (eQMS, LMS, etc.), ensuring systems are fit-for-purpose, integrated, and capable of supporting commercial operations, with strong data integrity controls.
- Build and mature a risk-based supplier quality management program, ensuring suppliers are qualified, monitored, and capable of supporting commercial manufacturing and distribution requirements.
- Support the implementation of QMS performance metrics and quality KPIs, enabling data-driven insights, proactive risk identification, and executive-level visibility.
- Support internal audit program, focused on identifying systemic gaps and ensuring readiness for commercial inspections.
Candidate Requirements
- BS/MS degree in a scientific discipline.
- 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years in leadership roles within Quality or related functions.
- 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.
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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