Supply Chain Operations - Life Sciences Manufacturing Quality - Manager

EY•Hartford, DC

17h•$128,400 - $267,400

About The Position

As a Manager in Supply Chain Manufacturing Quality, you will work with pharmaceutical, biotechnology, and medical-device manufacturers to improve collaboration among quality, QA/QC, laboratory, manufacturing, and technology teams. This client-facing, techno-functional delivery role leads defined quality-transformation workstreams from assessment and requirements through solution design, implementation, testing, adoption, and stabilization, with a focus on quality-system performance, data integrity, and inspection readiness. You will facilitate decisions with client quality and laboratory teams, translate domain needs into actionable requirements, coordinate functional and technical specialists, and take ownership of workstream quality and progress. You will also contribute to broader program planning and value realization, working with senior engagement leaders on cross-program decisions and commercial matters. The role may require 80–100% travel, depending on business and role requirements, and candidates must be legally authorized to work in the United States without current or future employer sponsorship.

Requirements

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
At least 7 years of relevant experience in Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data and AI, technology consulting, or a related field.
Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation or deployment phase.
Experience in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
Experience translating quality-domain needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
Practical understanding of GxP/GMP and documentation, change-control, data-integrity, and electronic-records-and-signatures considerations relevant to digital quality solutions.
Ability to travel as needed based on business and role requirements; travel can range from 80–100%.
Legally authorized to work in the U.S. without the need for employer sponsorship, now and in the future.
Practical understanding of Life Sciences Manufacturing Quality and the connections among quality, QA/QC, laboratory operations, manufacturing, and supply chain.
Ability to turn quality-domain problems into clear workflows, functional requirements, user stories, data needs, interface requirements, and testable acceptance criteria.
Working knowledge of eQMS/QMS platforms and digital-quality workflows, with technical fluency to collaborate with quality-systems specialists, architects, data engineers, developers, and cybersecurity teams.
Familiarity with LIMS, assays, stability data, OOS/OOT traceability, batch and equipment data, data contextualization, APIs, and laboratory-informatics connectivity patterns relevant to the solution.
Sound judgment about analytics or AI use, required data and controls, and how people will use outputs in quality or laboratory workflows.
Strong workshop facilitation, structured problem-solving, client communication, team coordination, and delivery-risk management skills.

Nice To Haves

Experience with drug substance, drug product, biologics, sterile manufacturing, medical devices, or clinical-to-commercial scale-up quality processes.
Delivery experience with eQMS/QMS platforms, LIMS, electronic batch records, connected-worker tools, quality analytics, or manufacturing/quality data platforms.
Familiarity with quality risk management frameworks such as ICH Q9, audit-trail and traceability requirements, and electronic-records-and-signatures standards such as 21 CFR Part 11, as relevant to client systems.
Awareness of data-integrity practices and controls relevant to GxP laboratory and quality systems.
Familiarity with quality analytics and continuous-improvement practices, including using quality, laboratory, and process data to monitor performance, identify recurring events, and support root-cause analysis.
Experience supporting computer system validation or risk-based computer software assurance where applicable to the regulated product and system.
Experience with multi-site deployments, quality-system harmonization, technology transfer, or development of reusable solution assets.
A relevant program-management, quality, cloud, data, or manufacturing-technology certification.

Responsibilities

Lead client-facing Life Sciences Manufacturing Quality transformation workstreams, owning plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and engagement with quality and laboratory teams.
Translate priorities such as right-first-time execution, cycle-time reduction, fewer deviations and nonconformances, CAPA effectiveness, and inspection readiness into process designs, requirements, acceptance criteria, and measurable improvements.
Develop functional designs for quality capabilities including deviations and investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition and release, review by exception, and quality risk management.
Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, laboratory-instrument, and informatics systems with architecture, quality-systems, and cybersecurity specialists.
Define and review data mappings, batch and investigation context, master-data needs, interface specifications, and data-quality controls for quality reporting, analytics, and AI use cases.
Help deliver quality analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, human-in-the-loop review, governance, and controls.
Work with client quality and validation teams to incorporate applicable GxP/GMP, data-integrity, electronic-records-and-signatures, controlled-change, and validation or risk-based assurance requirements into workstream deliverables, including audit trails and traceability.
Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and workstream handover.
Facilitate working sessions among quality, QA/QC, manufacturing, laboratory, MS&T, supply chain, IT, data, and technology-vendor teams; escalate decisions and dependencies affecting the broader program.
Manage workstream scope, schedule, resources, quality, and risks; provide status updates and contribute to estimates, proposals, and follow-on opportunity shaping.
Coach junior team members, review their work products, and capture reusable requirements, design patterns, and delivery lessons.