Life Sciences Quality Transformation Manager

EY; Los Angeles (CA); Remoto; USD 128.000 - 267.000; Tempo pieno

Vantaggi offerti da questo lavoro

Total Rewards package

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation workstreams. You will strengthen quality systems, compliance, audit readiness, and product quality across manufacturing and laboratory operations, applying digital QMS, data, AI, and delivery skills in regulated environments.

In this techno-functional role, you will coordinate with client quality and lab teams, translate quality needs into actionable requirements, and oversee

Competenze

• Bachelor’s degree or higher in Life Sciences, Engineering, Quality, Supply Chain, Information Systems, Business, or related field.
• At least 7 years of 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 in pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environments.
• Ability to translate quality-domain needs into process, functional, data, integration, or testing deliverables and coordinate contributors.
• Knowledge of GxP/GMP and related documentation, change-control, data-integrity, and e-signatures.
• Willingness to travel 80-100% as needed.

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 via workshops and data analysis.
• Translate priorities into designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, complaints, audits, inspection readiness, and quality risk management.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and laboratory-instrument systems.
• Define data mappings, batch context, master-data needs, interface specs, and data-quality controls for reporting, analytics, and AI use cases.
• Support quality analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and governance.
• Ensure validation, electronic records and signatures, and auditable change-management are reflected in workstream deliverables.
• Oversee configuration, testing, defect resolution, deployment readiness, training, cutover, hypercare, and handover.
• Facilitate sessions across quality, QA/QC, manufacturing, lab, IT, data, and vendor teams; manage dependencies for the broader program.
• Manage scope, schedule, resources, quality, risks; contribute to estimates, proposals and follow-on opportunities.
• Mentor junior team members and capture reusable requirements and delivery lessons.

Conoscenze

Bachelor's degree

7+ years experience

Client-facing leadership

Regulated manufacturing

Quality data AI

GxP/GMP knowledge

Travel 80-100%

Formazione

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation workstreams. You will strengthen quality systems, compliance, audit readiness, and product quality across manufacturing and laboratory operations, applying digital QMS, data, AI, and delivery skills in regulated environments.

In this techno-functional role, you will coordinate with client quality and lab teams, translate quality needs into actionable requirements, and oversee