Scholar Rock
Director, Global Quality Systems and Compliance
Cambridge, MA · Director
Sponsorship not specified$200k-$245kDetected 77 days ago
ComplianceAuditingLeadershipInternal AuditGxP
About the role
- 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.
- Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
- Scholar Rock is an Equal Opportunity Employer.
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.
- 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.
- Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution.
Nice to have
- Scale the GxP training program, implementing role-based curricula, improving training effectiveness, and ensuring sustainable compliance as the organization grows.
- 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.
- Hands-on experience with systems such as Veeva Vault is preferred.
- Highly proactive, decisive, and capable of independently managing key initiatives.
Compensation
- $200k-$245k
Benefits
- Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability.
Company info
- 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.
- 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.
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This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.