Life Sciences Quality Transformation Manager

EY

Grand Rapids (MI)

Remoto

USD 150.000 - 230.000

Tempo pieno

8 giorni fa

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Descrizione del lavoro

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformation across pharmaceutical, biotech, and medical-device manufacturing. You will drive cross-functional workstreams from assessment to solution design, focusing on data integrity, inspection readiness, and AI-enabled quality improvements.

The role requires 7+ years in Life Sciences quality and experience in regulated environments, with travel up to 100%.

Competenze

Bachelor’s degree in life sciences or related field.
7+ years in Life Sciences Manufacturing Quality or related.
Experience leading client-facing quality or digital workstreams.
Experience in regulated pharma environments.
Travel 80–100%.
Authorized to work in the U.S. without sponsorship.

Mansioni

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and engagement.
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 across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems with architects and cybersecurity teams.
Define data mappings, master-data needs, interface specs, and data-quality controls for reporting, analytics, and AI uses.
Help deliver quality analytics and AI use cases with data readiness, governance, and human-in-the-loop review.
Work with validation teams to reflect GxP/GMP and electronic-records requirements in deliverables.
Oversee configuration, testing, deployment readiness, training, and cutover support.
Facilitate sessions across quality, manufacturing, laboratory, IT, data, and vendors to accelerate decisions.
Manage scope, schedule, resources, quality, risks; contribute to estimates and proposals.
Coach junior staff and capture reusable requirements and design patterns.