Description
Sr. Director, US Quality Assurance
Team: Global Quality
Location: Cambridge, MA
Commitment: Full-Time
Workplace Type: hybrid
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
Scholar Rock is seeking an experienced and motivated Senior Director of US Quality Assurance. Reporting to the Head of Global Quality, this position provides strategic and operational leadership for US Quality Assurance with a strong focus on external partner governance, quality risk management, and scalable quality infrastructure to support development through commercialization.
Position Responsibilities
- Lead the US Quality Assurance function for external GxP biologics operations, including oversight of CMOs, contract laboratories, and other critical service providers.
- Provide QA oversight for external manufacturing, testing, release support, deviations, investigations, CAPAs, change controls, product impact assessments, and disposition-related decisions.
- Design and maintain a robust, scalable product disposition program for clinical trial material as well as commercial products across multiple markets.
- Ensure continuous inspection readiness across outsourced operations and support health authority inspections, partner inspections, and due diligence activities.
- Monitor partner quality performance through defined metrics, scorecards, and governance forums; identify trends and proactively escalate compliance or execution risks.
- Partner cross-functionally to assess quality risk associated with process changes, deviations, investigations, comparability activities, tech transfer, and supply continuity issues.
- Provide strategic guidance on quality requirements for product lifecycle activities, including clinical supply, commercial readiness, distribution, complaints, and post-approval changes.
- Build and develop internal QA capabilities, processes, and team structure appropriate for a virtual biotech operating model.
- Drive a culture of quality, accountability, and proactive issue identification across internal stakeholders and external partners.
- Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).
Candidate Requirements
- BS/MS degree in a scientific discipline.
- 15+ years of experience in the pharmaceutical/biotech industry (including meaningful experience in outsourced/virtual operating models), with 7+ years in leadership roles within Quality or related functions
- Deep knowledge of GMP/GxP requirements, FDA/EMA expectations, ICH guidance, and risk-based quality management principles.
- Demonstrated success overseeing external manufacturers, testing laboratories, suppliers, and quality service providers.
- Experience supporting biologics products across development stages; commercial and launch readiness experience strongly preferred.
- Strong judgment, executive presence, and the ability to balance strategic thinking with hands-on execution.
- Highly proactive, decisive, and capable of independently managing key initiatives.
- Engaged people manager committed to building culture as well as mentorship and talent development
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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