Senior Quality & Digital QMS Lead (Life Sciences)

EY; Lorida (FL); Remote; USD 97,000 - 195,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) plan

Paid time off

Job summary

EY seeks a Senior Life Sciences Quality professional to design, build, test, and deploy digital solutions across regulated quality environments. You will connect QA/QC, laboratory, and manufacturing data, guiding the implementation from requirements through stabilization.

The role emphasizes GxP controls, data integrity, and AI-enabled quality workflows, with collaboration across QA, QC, IT, and regulatory teams. Travel may be required.

Qualifications

• Bachelor’s degree required in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and equipment data, and current-state pain points through interviews and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, and acceptance criteria for digital quality solutions.
• Support design and implementation of digital-quality capabilities spanning deviations and nonconformances, CAPA, change control, audits and inspection readiness, supplier quality, batch disposition and release, review by exception, and risk management.
• Design and improve digital-quality workflows using eQMS/QMS platforms, including workflow configuration, records management, approvals, escalation paths, and reporting.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other data systems; support assays, stability programs, OOS/OOT traceability, deviation and CAPA analysis, and batch-review workflows.
• Develop and review quality and laboratory data models, source-to-target mappings, data-quality rules, and contextualized datasets linking quality events to products, materials, batches, methods, specifications, instruments, equipment, and process conditions.
• Work with solution architects on interface specifications, APIs, and secure movement of data across site and enterprise environments.
• Configure or prototype solution components and document design decisions for review by quality and client leads.
• Prepare and execute functional and integration test scripts, record defects, and maintain traceability between requirements, risks, controls, and test evidence.
• Support deployment readiness, training, hypercare, and handover with clear documentation.
• Partner with client quality and validation teams to prepare or review documentation addressing GxP/GMP, data integrity, electronic records, validation, audit trails, and traceability.
• Integrate and contextualize data to identify recurring events, detect trends, and improve quality decision-making.
• Contribute to governed AI applications for Quality, including AI-assisted investigations and anomaly detection with human-in-the-loop review.

Skills

Quality-domain expertise

Digital QMS skills

QA/QC and laboratory integration

Quality data & integration

Delivery discipline

Technical communication

GxP & quality-system controls

Analytical judgment

Education

Bachelor’s degree in life sciences/quality/engineering/CS

Tools

LIMS

Laboratory systems

Chromatography data systems

Stability management

Assays

Specifications

Job description

EY seeks a Senior Life Sciences Quality professional to design, build, test, and deploy digital solutions across regulated quality environments. You will connect QA/QC, laboratory, and manufacturing data, guiding the implementation from requirements through stabilization.

The role emphasizes GxP controls, data integrity, and AI-enabled quality workflows, with collaboration across QA, QC, IT, and regulatory teams. Travel may be required.