Life Sciences Quality Transformation Lead

EY; Baltimore (MD); Remoto; USD 128.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k)

Paid time off options

Descrizione del lavoro

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory, and manufacturing operations. You will drive workstreams from assessment through solution implementation, focusing on quality-system performance, data integrity, and inspection readiness.

You will collaborate with senior engagement leaders, translate quality needs into actionable requirements, and coordinate with architecture, cybersecurity, and quality-systems teams to

Competenze

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, or a related discipline.
• At least 7 years of relevant experience in Life Sciences Manufacturing Quality or related field.
• Experience leading client-facing quality, digital, data, or technology workstreams through design and at least one implementation.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Ability to travel 80-100% as needed.
• Authorized to work in the U.S. without sponsorship.

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, 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 requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and document-management systems.
• Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
• Deliver quality analytics and AI use cases with governance and controls.
• Work with validation teams to reflect GxP, data-integrity, and electronic-records requirements in deliverables.
• Oversee configuration, testing, deployment readiness, training, and handover.
• Facilitate cross-functional sessions across quality, manufacturing, IT, data, and vendors.
• Manage scope, schedule, resources, and risks; contribute to proposals and follow-on opportunities.
• Coach juniors and capture reusable lessons.

Conoscenze

Quality management

GxP/GMP

Data analytics

AI concepts

Project leadership

Formazione

Bachelor's degree

Strumenti

eQMS/QMS

LIMS

MES/MOM

ERP

Descrizione del lavoro

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory, and manufacturing operations. You will drive workstreams from assessment through solution implementation, focusing on quality-system performance, data integrity, and inspection readiness.

You will collaborate with senior engagement leaders, translate quality needs into actionable requirements, and coordinate with architecture, cybersecurity, and quality-systems teams to