Life Sciences Quality Transformation Manager

EY

Chattanooga (TN)

In loco

USD 128.000 - 235.000

Tempo pieno

8 giorni fa

Una candidatura completa in un minuto

Curriculum e lettera di presentazione personalizzati, pronti da inviare.

Supera i filtri ATS

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k)

Paid time off

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams to strengthen quality systems, compliance, inspection readiness and product quality across manufacturing and laboratory operations. The role blends practical quality-domain knowledge with digital QMS, data and AI to turn needs into workable solutions in regulated environments.

This techno-functional delivery role requires facilitation of decisions with client teams,

Competenze

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related field.
7+ years of relevant experience in Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data and AI, technology consulting, 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 working in pharma/biotech/medical-device or similarly regulated manufacturing environments.
Ability to translate quality-domain needs into process, functional, data, integration, or testing deliverables and coordinate business and technical contributors.
Knowledge of GxP/GMP, electronic records/signatures, change-control, data integrity considerations in digital quality solutions.
Ability to travel 80-100% as required.
Legal authorization to work in the U.S. without sponsorship now and in the future.

Mansioni

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans, deliverables, risks, decisions and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps and site constraints.
Translate priorities into process designs, requirements, acceptance criteria and measurable improvements.
Develop functional designs for deviations, CAPA, change control, audits and inspection readiness, supplier quality, batch disposition and quality risk management.
Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP and informatics systems with architects and cybersecurity specialists.
Define and review data mappings, master-data needs, interface specifications and data-quality controls for reporting and analytics.
Support AI use cases by assessing data readiness, workflow fit and governance.
Oversee configuration activities, testing, deployment readiness, training, cutover and handover for your workstream.
Facilitate cross-functional sessions across quality, manufacturing, laboratory, IT and vendors to accelerate decisions.
Manage scope, schedule, resources, quality and risks; contribute to estimates and follow-on opportunities.
Coach junior team members and capture reusable requirements and lessons learned.