Associate Director, QC Analytics

 

The Role

The Associate Director, QC Analytics provides operational leadership for routine GMP analytical testing at ElevateBio’s Waltham site and leads a team of managers responsible for seven-day laboratory operations. This role is accountable for predictable execution of product release and in-process testing, laboratory excellence, right-first-time performance, and timely, compliant reporting of results. The Associate Director leads the testing organization through disciplined capacity planning, daily management, schedule control, performance management, and rapid resolution of operational barriers across the full operating week. The role partners closely with Quality Control Analytical Technologies (QCAT), which provides technical enablement and analytical lifecycle leadership, to ensure new or changed methods, equipment, controls, critical reagents, and digital capabilities transition into stable, sustainable routine operations.

Here’s What You’ll Do

Release Testing Execution

• Own the integrated plan for routine release, in-process, characterization, and other assigned GMP testing; align capacity, staffing, instruments, and seven-day coverage to demand.
• Use tiered daily management and clear escalation to control sample readiness, analyst qualification, instrument availability, testing, review, and result reporting.
• Partner with Manufacturing to prioritize and rapidly execute STAT in-process samples within required decision windows; immediately escalate delays or risks.
• Partner with QC Logistics to align sample plans, receipt and chain of custody, contract laboratory dependencies, and stability pulls with testing schedules.

Laboratory Excellence

• Lead safe, compliant, inspection-ready laboratory operations with clear work allocation, standard work, trained personnel, and available equipment, reagents, and consumables.
• Drive right-first-time execution and reduce repeat work, documentation errors, queue time, and schedule variability through structured problem solving and continuous improvement.
• Monitor schedule adherence, turnaround time, right-first-time performance, repeat testing, investigation aging, review cycle time, capacity utilization, and backlog health.

QCAT Interface and Operational Readiness

• Partner with QCAT on method transfer, qualification and validation, equipment qualification, controls and critical reagents, lifecycle changes, and Digital QC initiatives.
• Define and confirm readiness for operational handoff, including approved methods and specifications, trained analysts, qualified equipment and systems, data workflows, troubleshooting guidance, materials, and sustainable capacity.
• Implement QCAT-enabled changes through controlled deployment and post-implementation monitoring, and provide routine-use data and feedback for lifecycle improvement.
• Maintain clear accountability: QCAT leads technical enablement and analytical lifecycle activities; QC Analytics owns routine execution and delivery after handoff.

Quality, Compliance, and Investigations

• Ensure testing, records, review, and reporting meet cGMP, approved procedures, specifications, quality agreements, data-integrity expectations, and program commitments.
• Lead operational response to laboratory events, deviations, atypical or out-of-specification results, CAPAs, change controls, and risks; partner with QCAT and Quality Assurance when technical lifecycle expertise is required.
• Represent QC Analytics during audits, inspections, governance meetings, release-readiness reviews, and operational escalations.

People and Organizational Leadership

• Lead and develop a team of managers responsible for seven-day laboratory operations and the broader testing organization, with clear objectives, decision rights, coverage expectations, and accountability.
• Build qualification, cross-training, succession, resource, and capability plans that support demand and reduce single points of failure.
• Create an inclusive, high-accountability culture grounded in safety, quality ownership, transparent communication, and continuous learning.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Chemistry, Molecular Biology, Pharmaceutical Sciences, or a related scientific discipline; an advanced degree is preferred.
• At least 10 years of relevant experience in a GMP Quality Control or analytical laboratory environment, including progressive people and operational leadership responsibility.
• Demonstrated leadership of routine GMP testing supporting product release in biotechnology, pharmaceutical, biologics, cell therapy, gene therapy, or another regulated environment.
• Demonstrated ability to improve schedule reliability, laboratory flow, right-first-time performance, and capacity utilization through daily management, standard work, metrics, and structured problem solving.
• Strong working knowledge of cGMP laboratory controls, data integrity, method execution, specifications, laboratory investigations, deviations, CAPAs, change control, and inspection readiness.
• Experience with analytical technologies relevant to advanced therapies, such as molecular methods, flow cytometry, immunoassays, chromatography, and cell-based assays, is preferred.
• Experience operating at the interface between routine testing and analytical lifecycle or technical teams, including method transfer, qualification, validation, equipment qualification, and digital laboratory implementation.
• Experience with laboratory systems such as LIMS, CDS, ELN, SDMS, QMS, CMMS, ERP, or related platforms.
• Strong capacity-planning, prioritization, risk-management, communication, and stakeholder-management skills in a multi-program or CDMO environment.
• Proven ability to develop leaders and teams, manage competing priorities, make timely decisions, and communicate clearly with clients, technical partners, Quality Assurance, Manufacturing, and senior leadership.

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• 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 with use of arms, wrists and hands

The budgeted range for this position is $165,000 - $225,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.