Sr. Director, External & CMC Quality Assurance

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