Life Sciences Quality Transformation Manager (Digital QMS)
EY
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Benefits offered by this job
Job summary
EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformations across quality systems and lab operations in the US. You will drive end-to-end workstreams from assessment to implementation, focusing on data integrity, inspection readiness, and regulatory alignment.
The role is techno-functional, coordinating quality and lab teams with IT and vendors, delivering measurable improvements, and supporting program-level decisions and value
Qualifications
- Bachelor's degree in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
- Experience leading client-facing quality/digital/tech workstreams.
- Familiarity with eQMS/QMS, LIMS, and related systems.
Responsibilities
- Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
- Assess current-state quality processes, user needs, system landscapes, data flows and gaps.
- Translate priorities into process designs, requirements and acceptance criteria.
- Develop functional designs for deviations, CAPA, change control, audits and inspection readiness.
- Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP and other systems.
- Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
- Help deliver quality analytics and AI use cases with data readiness and governance.
Skills
Education
Job description
EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformations across quality systems and lab operations in the US. You will drive end-to-end workstreams from assessment to implementation, focusing on data integrity, inspection readiness, and regulatory alignment.
The role is techno-functional, coordinating quality and lab teams with IT and vendors, delivering measurable improvements, and supporting program-level decisions and value
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