Senior Director, US Quality Assurance
Scholar Rock
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • United States
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Salary
💰 $245,000 - $335,000 per year
Job Level
About the role
- 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).
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
Benefits
- Health insurance
- Retirement plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMPGxPrisk-based quality managementproduct lifecycle managementquality assuranceclinical trial materialCAPAchange controlproduct impact assessmentbiologics
Soft Skills
strategic thinkingexecutive presenceproactive managementdecisivenesspeople managementmentorshiptalent developmentissue identificationcollaborationaccountability