Life Sciences Quality Transformation Manager

EY; Houston (TX); On-site; USD 128,000 - 257,000; Full time

Job summary

EY in the United States is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled quality transformation for pharma, biotech and medical-device clients. You will drive quality-system performance, data integrity and inspection readiness across manufacturing and laboratory operations.

You’ll coordinate multi-disciplinary teams, translate complex quality needs into actionable requirements, and oversee design, testing, and deployment of digital QMS solutions with a strong

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or related discipline.
• At least 7 years of Life Sciences Manufacturing Quality, QA/QC, or related field.
• Experience leading client-facing quality, digital, data, or technology workstreams through design and deployment.
• Experience in pharmaceutical, biotechnology, medical-device, or similarly regulated manufacturing environments.
• Ability to translate quality-domain needs into process, data, integration, or testing deliverables.
• Practical understanding of GxP/GMP and 21 CFR Part 11 considerations.
• Ability to travel 80–100% as needed.
• Authorized to work in the U.S. without employer sponsorship.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into functional designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, and inspection readiness.
• Coordinate integrations across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and informatics systems.
• Define data mappings and data-quality controls for reporting, analytics, and AI use cases.
• Oversee testing, deployment readiness, training, cutover support, and hypercare.
• Coach junior team members and capture reusable requirements and design patterns.

Skills

Quality management

Data analysis

Workshop facilitation

LIMS familiarity

GxP/GMP understanding

Education

Bachelor's degree

Tools

eQMS/QMS

LIMS

ERP systems

Document management

Job description

EY in the United States is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled quality transformation for pharma, biotech and medical-device clients. You will drive quality-system performance, data integrity and inspection readiness across manufacturing and laboratory operations.

You’ll coordinate multi-disciplinary teams, translate complex quality needs into actionable requirements, and oversee design, testing, and deployment of digital QMS solutions with a strong