Senior Director, Quality Control

ElevateBio•Waltham, MA

2d•Onsite

About The Position

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. This includes 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 QC’s operating strategy, capacity and resource plan, performance system, and leadership model to meet manufacturing, client, and business commitments while sustaining laboratory excellence and data integrity. The role leads the integrated QC organization and develops its management and technical leaders, aligning staffing, seven-day coverage, facilities, equipment, systems, operating expenses, and capital with demand. The position provides oversight of QCAT and analytical lifecycle activities, including client technical interfaces, technology and method transfer, qualification and validation, equipment qualification, controls and critical reagents, and Digital QC. It also ensures that QC activities comply with cGMP, procedures, specifications, quality agreements, data-integrity expectations, and regulatory commitments; represents QC in client governance, audits, inspections, release-readiness reviews, and escalations; and serves as a senior QC partner to Manufacturing and cross-functional site organizations.

Requirements

Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
At least 15 years of progressive experience in GMP Quality Control or analytical laboratory operations, including substantial leadership of managers and multifunctional teams.
Demonstrated leadership of a broad QC organization supporting complex biopharmaceutical, biologics, cell therapy, gene therapy, or other regulated manufacturing operations.
Strong knowledge of GMP laboratory controls, analytical testing, microbiology, environmental monitoring, raw materials, stability, sample management, analytical lifecycle activities, laboratory systems, data integrity, contract laboratory oversight, and quality systems.
Demonstrated success improving schedule reliability, turnaround time, right-first-time performance, capacity utilization, investigation management, and inspection readiness.
Experience leading seven-day operations and partnering with Manufacturing on time-critical in-process testing and operational decision windows.
Experience supporting client audits, regulatory inspections, client governance, and significant quality or delivery escalations.
Strong strategic planning, financial stewardship, organizational design, talent development, communication, decision-making, and stakeholder-management capabilities.
Ability to stand, walk, bend, and stretch for extended periods.
Ability to lift 15–20 lbs.
Ability to push, pull, bend, kneel, twist, and climb step ladders while wearing PPE.
Ability to perform routine repetitive motions using arms, wrists, and hands.

Nice To Haves

An advanced degree.
Lean Six Sigma certification or demonstrated experience applying Lean Six Sigma, Lean Lab, and Digital Lab practices to improve laboratory flow, capacity, data visibility, and operational performance.
Experience in a multi-program or CDMO environment.

Responsibilities

Lead the integrated QC organization, operating model, objectives, decision rights, talent strategy, and capability roadmap.
Develop QC management and technical leaders and align headcount, seven-day coverage, facilities, equipment, systems, operating expense, and capital with demand.
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 and prioritization and rapidly execute 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.
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 and clear, accountable handoffs between QCAT and operational laboratories, with sustainable capacity and post-implementation monitoring.
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.
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.