Life Sciences Quality Transformation Lead

EY; St. Louis (MO); In loco; USD 154.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k) plans

Paid time off options

Descrizione del lavoro

EY, a leader in professional services, seeks a Manager in Life Sciences Manufacturing Quality to drive technology-enabled quality transformations across QA/QC, manufacturing, and laboratory operations for pharma, biotech, and medical-device clients.

You will turn quality needs into actionable requirements, coordinate specialists, and push data integrity, inspection readiness, and AI-enabled analytics across regulated environments.

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.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one deployment.
• Experience in pharmaceutical/biotech/medical-device or regulated manufacturing environments.
• Ability to translate quality needs into process, data, integration, or testing deliverables.

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, data flows, and site constraints through workshops and data analysis.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits and inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and laboratory systems with architects and cybersecurity specialists.
• Define and review data mappings, master-data needs, interface specs, and data-quality controls for reporting and AI use cases.
• Help deliver quality analytics and AI use cases with governance and human-in-the-loop review.
• Work with validation teams to reflect GxP/GMP, data-integrity, and electronic-records-and-signatures considerations.
• Oversee configuration activities, testing, deployment readiness, training, hypercare, and handover.
• Facilitate sessions across quality, manufacturing, IT, data, and vendor teams; manage dependencies.
• Manage scope, schedule, resources, risks; contribute to proposals and follow-on opportunities.
• Coach junior team members and capture reusable requirements and design patterns.

Conoscenze

Quality management

QA/QC

eQMS/QMS

LIMS

Data analytics

AI in quality

Process design

Cybersecurity collaboration

Regulatory knowledge (GxP/GMP)

Change control

Formazione

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

Strumenti

LIMS

ERP

Quality analytics tools

Descrizione del lavoro

EY, a leader in professional services, seeks a Manager in Life Sciences Manufacturing Quality to drive technology-enabled quality transformations across QA/QC, manufacturing, and laboratory operations for pharma, biotech, and medical-device clients.

You will turn quality needs into actionable requirements, coordinate specialists, and push data integrity, inspection readiness, and AI-enabled analytics across regulated environments.