Senior Quality & Digital QMS Lead (Life Sciences)

EY; San Francisco (CA); À distance; USD 97 000 - 178 000; Plein temps

Résumé du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help pharma, biotech, and medical-device clients connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions. You will own technical deliverables across the delivery lifecycle, from requirements through validation and deployment.

Join EY to shape quality programs and AI-enabled workflows within regulated environments, collaborating with QA, QC, IT, and business teams and traveling as needed to client sites

Qualifications

• Bachelor's degree in life sciences, quality, engineering or related field.
• At least 3 years of Life Sciences quality, QA/QC, or related experience.
• Experience with digital QMS and laboratory systems.

Responsabilités

• Assess quality and laboratory workflows, user needs, and data interfaces through interviews and data review.
• Document process flows, requirements, data mappings, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, audits, and release.
• Configure or prototype solution components and document design decisions for review.
• Prepare and execute test scripts, defects, and ensure traceability between requirements and validation evidence.
• Collaborate with client teams to ensure GxP compliance and data integrity across systems.

Connaissances

Quality-domain expertise

Digital QMS

QA/QC integration

Data interpretation

Technical communication

GxP/GMP knowledge

Analytical judgment

Formation

Bachelor’s degree in life sciences, quality, engineering

Outils

LIMS

eQMS

QMS

APIs

Description du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help pharma, biotech, and medical-device clients connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions. You will own technical deliverables across the delivery lifecycle, from requirements through validation and deployment.

Join EY to shape quality programs and AI-enabled workflows within regulated environments, collaborating with QA, QC, IT, and business teams and traveling as needed to client sites