Life Sciences Quality Transformation Lead

EY; Palo Alto (CA); On-site; USD 161,000 - 267,000; Full time

Job summary

EY in the United States is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation across quality systems, data integrity, and inspection readiness. You will guide workstreams from assessment to implementation in regulated environments, collaborating with QA/QC, manufacturing, and IT teams.

This techno-functional role requires translating quality needs into actionable requirements, designing controls, and ensuring compliance with GxP, 21

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business or related discipline.
• 7+ years in Life Sciences Manufacturing Quality, QA/QC, or related field.
• Experience leading client-facing quality/ digital workstreams through design and at least one deployment.
• Experience in pharmaceutical/biotech/medical-device regulated manufacturing.
• Translating quality-domain needs into process, data, and testing deliverables.
• Understanding of GxP/GMP, electronic records/signatures, and validation concepts.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformations with clear ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, inspection readiness, supplier quality, and batch disposition.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP and laboratory instruments.
• Define data mappings, master-data needs, interface specs, and data-quality controls for reporting and AI use cases.
• Support AI-assisted investigations, data readiness, governance, and controls.
• Ensure compliance with audit trails, electronic Records, and 21 CFR Part 11 related considerations.
• Oversee testing, defect resolution, deployment readiness, training, and handover for your workstream.
• Facilitate cross-functional sessions across quality, manufacturing, lab, IT, and vendors.

Skills

Quality processes

Data analysis

Workshop facilitation

Client communication

Delivery management

Education

Bachelor’s degree in life sciences/engineering/quality/info systems

Tools

LIMS

Job description

EY in the United States is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation across quality systems, data integrity, and inspection readiness. You will guide workstreams from assessment to implementation in regulated environments, collaborating with QA/QC, manufacturing, and IT teams.

This techno-functional role requires translating quality needs into actionable requirements, designing controls, and ensuring compliance with GxP, 21