Senior Quality & Digital QMS Lead – Life Sciences

EY; Wichita (KS); Presencial; USD 97.000 - 203.000; Jornada completa

Descripción de la vacante

EY is seeking a Senior in Supply Chain Manufacturing Quality to help life sciences clients connect quality, laboratory, and manufacturing needs with deployable technology. You will own deliverables across the delivery lifecycle, from requirements through deployment, while collaborating with QA, validation, IT, and client teams.

The role emphasizes GxP controls, data integrity, and end-to-end traceability, with opportunities to contribute to AI-enabled quality workflows and continuous improvement

Formación

• Bachelor's degree in life sciences, quality, engineering, information systems, or related field.
• At least 3 years of relevant Life Sciences quality, QA/QC, or digital QMS experience.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience with deviations, investigations, CAPA, change control, audits, or risk management.
• Ability to travel as needed; 80-100% suggested.
• Authorized to work in the U.S. without sponsorship.
• Experience producing technical delivery artifacts (requirements, data mappings, interface specs, test scripts).

Responsabilidades

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and data points through interviews and data review.
• Document process flows, user stories, functional requirements, data mappings, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, and batch release.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integrate with other systems.
• Connect QA/QC and laboratory data across LIMS, eQMS/QMS, MES, ERP, and related systems.
• Prepare and execute functional and integration test scripts, record defects, and maintain traceability.

Conocimientos

Quality-domain expertise

Digital QMS

QA/QC integration

Data integration

AI/Analytics for Quality

Technical communication

GxP knowledge

Analytical judgment

Educación

Bachelor's degree in Life Sciences / Quality / Engineering / Information Systems / related field

Herramientas

LIMS

eQMS/QMS platforms

Descripción del empleo

EY is seeking a Senior in Supply Chain Manufacturing Quality to help life sciences clients connect quality, laboratory, and manufacturing needs with deployable technology. You will own deliverables across the delivery lifecycle, from requirements through deployment, while collaborating with QA, validation, IT, and client teams.

The role emphasizes GxP controls, data integrity, and end-to-end traceability, with opportunities to contribute to AI-enabled quality workflows and continuous improvement