Life Sciences Quality Delivery Lead

EY

Hoboken (NJ)

Remote

USD 128,000 - 257,000

Full time

8 days ago

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Job summary

EY is seeking a Manager in Life Sciences Manufacturing Quality to lead technology-enabled transformation workstreams across pharmaceutical, biotechnology, and medical-device manufacturing. You will focus on quality-system performance, data integrity, and inspection readiness, coordinating across QA/QC, manufacturing, and IT teams.

This techno-functional role requires translating quality needs into actionable requirements, overseeing design, testing, deployment, and validation activities, and

Qualifications

Bachelor's degree in life sciences, engineering, quality, or related field.
7+ years of Life Sciences Manufacturing Quality experience.
Experience leading client-facing quality or digital quality workstreams.
Knowledge of GxP/GMP, 21 CFR Part 11, and data integrity.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes, data flows, and site constraints.
Translate priorities into designs, requirements, and acceptance criteria.
Coordinate integration of eQMS/QMS, LIMS, MES/MOM, ERP systems.
Oversee testing, deployment readiness, training, and handover.

Skills

Quality management

Life sciences

Data analytics

AI in quality

Project leadership

Education

Bachelor's degree

Tools

eQMS

LIMS

QMS platforms

Job description

This techno-functional role requires translating quality needs into actionable requirements, overseeing design, testing, deployment, and validation activities, and

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