Executive Director Quality Assurance, External Manufacturing

Essential Functions

• Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, with escalation of critical risks to VP-level as appropriate.
• Provide end-to-end QA leadership for externally executed GxP activities, including manufacturing and release of drug substance, drug product, components, and critical raw materials.
• Serve as the senior QA leader for external operations, representing Quality in cross-functional and executive forums, and influencing decisions across Technical Operations, CMC, Regulatory, and Supply Chain.
• Establish and maintain strategic partnerships with external partners, driving accountability, performance management, and continuous improvement.
• Lead quality governance across the external network, including KPIs, escalation pathways, and risk-based oversight models focused on critical processes and high-risk partners.
• Oversee and drive resolution of complex, cross-organizational quality issues, ensuring robust investigations, root cause analysis, and sustainable CAPAs.
• Provide oversight and decision authority for batch disposition and product release, ensuring timely, compliant supply of clinical and commercial materials.
• Drive inspection readiness across the external network, including PAI and global health authority inspections, and serve as a key QA representative during inspections.
• Provide strategic QA leadership for technology transfer, process validation, and lifecycle management across external sites.

Requirements

• BS/BA required, with a minimum of 16 years of progressive experience in Quality Assurance within biopharmaceuticals, including significant leadership in external manufacturing and CDMO oversight, vaccines experience desirable.
• Deep expertise in GMP regulations, FDA and global regulatory expectations, and ICH guidelines
• Extensive experience operating within a highly outsourced/CDMO-based manufacturing model
• Proven track record of leading complex external quality networks, driving performance and outcomes without direct authority
• Strong experience supporting technology transfer, process validation, and lifecycle management across multiple external sites
• Demonstrated success in inspection readiness and regulatory inspections, including pre-approval inspections (PAIs)
• Experience establishing governance frameworks, and performance metrics for external partners
• Strong background in risk management and quality systems, with the ability to apply risk-based decision-making in a GxP environment
• Proven ability to influence at the executive level, driving alignment across cross-functional teams and external partners
• Demonstrated experience building, leading, and scaling high-performing teams in a complex, fast-paced environment
• Strong business acumen, with the ability to balance quality, compliance, and supply continuity to support clinical and commercial objectives