ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role
The Senior Director, Quality Control leads all Quality Control operations at ElevateBio’s Waltham site, including QC Analytical Technologies (QCAT), QC Analytics, Testing Core, QC Microbiology, QC Raw Materials, and QC Logistics. The role is accountable for safe, compliant, inspection-ready, and predictable execution across a seven-day operating model, including product release and in-process testing, STAT support to Manufacturing, environmental and microbiological testing, raw material disposition, stability support, sample management, and analytical lifecycle enablement. The Senior Director establishes the QC operating strategy, capacity and resource plan, performance system, and leadership model required to meet manufacturing, client, and business commitments while sustaining laboratory excellence and data integrity.
Here’s What You’ll Do
QC Strategy and Leadership
Lead the integrated QC organization, operating model, objectives, decision rights, talent strategy, and capability roadmap.
Develop QC management and technical leaders while aligning headcount, seven-day coverage, facilities, equipment, systems, operating expense, and capital with demand.
Predictable QC Operations and Laboratory Excellence
Own safe, compliant, and predictable execution of product release and in-process testing, environmental and microbiological monitoring, raw material disposition, stability, sample management, and client commitments.
Ensure reliable seven-day operations through capacity planning, schedule control, tiered daily management, performance review, and timely escalation and recovery.
Partner with Manufacturing to align readiness, prioritization, and rapid execution of STAT in-process samples within required decision windows.
Drive laboratory excellence through standard work, right-first-time execution, efficient review and reporting, backlog control, structured problem solving, and continuous improvement.
Analytical Technologies and Lifecycle Enablement
Provide leadership oversight for QCAT, including client technical interface, technology and method transfer, qualification and validation, method lifecycle management, equipment qualification, controls and critical reagents, and Digital QC.
Ensure effective utilization of shared QC Resources, handoffs between QCAT and operational laboratories through clear readiness criteria, accountability, sustainable capacity, and post-implementation monitoring.
Quality, Compliance, and Partnership
Ensure QC activities meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and regulatory commitments.
Provide senior oversight of laboratory events, atypical or out-of-specification results, deviations, investigations, CAPAs, changes, risks, and inspection readiness.
Represent QC in client governance, audits, regulatory inspections, release-readiness reviews, and escalations; communicate performance, constraints, risks, and recovery plans clearly.
Serve as the senior QC partner to Manufacturing, Quality Assurance, Facilities & Engineering, MSAT, Regulatory Affairs, Supply Chain, Digital, Process and Analytical Development, and site leadership.
Requirements
Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; an advanced degree is preferred.
At least 15 years of progressive experience in GMP Quality Control or analytical laboratory operations, including substantial leadership of managers and multi-functional teams.
Demonstrated leadership of a broad QC organization supporting complex biopharmaceutical, biologics, cell…