Life Sciences Quality Transformation Manager

EY; Louisville (KY); Ibrido; USD 128.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Descrizione del lavoro

EY seeks a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems and data-enabled initiatives in regulated manufacturing environments. You’ll drive end-to-end workstreams from assessment through design, implementation, testing, and stabilization while focusing on data integrity, inspection readiness, and QMS improvements.

This techno-functional role requires coordinating quality and laboratory teams, translating needs into

Competenze

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
• At least 7 years of relevant Life Sciences Manufacturing Quality experience in QA/QC, quality technology, or related field.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation or deployment phase.
• Experience in pharmaceutical/biotech/medical-device or similarly regulated manufacturing environments.
• Ability to translate quality domain needs into process, data, integration, or testing deliverables and coordinate contributors.
• Familiarity with GxP/GMP, data integrity, and electronic-records-and-signatures considerations.

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 and data analysis.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations/nonconformances, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition, and QA processes.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management and lab informatics systems.
• Define and review data mappings, master-data needs, interface specifications, and data-quality controls for reporting and AI use cases.
• Help deliver quality analytics and AI use cases by assessing data readiness and governance.
• Work with client quality and validation teams to reflect GxP, data-integrity, electronic-records-and-signatures requirements in deliverables.
• Oversee configuration activities and lead testing, defect resolution, deployment readiness, training, and handover.
• Facilitate sessions across quality, manufacturing, laboratory, IT, and vendor teams; manage dependencies for the broader program.
• Manage scope, schedule, resources, quality, and risks; contribute to estimates, proposals, and follow-on opportunities.
• Coach junior team members and capture reusable requirements and delivery lessons.

Conoscenze

Quality transformation

Client-facing leadership

AI/data analytics awareness

Cross-functional collaboration

Formazione

Bachelor's degree in life sciences, engineering, quality, or related discipline

Strumenti

eQMS/QMS platforms

LIMS

Data-integrity standards (21 CFR Part 11)

Descrizione del lavoro

EY seeks a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems and data-enabled initiatives in regulated manufacturing environments. You’ll drive end-to-end workstreams from assessment through design, implementation, testing, and stabilization while focusing on data integrity, inspection readiness, and QMS improvements.

This techno-functional role requires coordinating quality and laboratory teams, translating needs into