Sr. Director, US Quality Assurance
Scorpion Therapeutics, Cambridge, MA, United States
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
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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
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