Life Sciences Quality Transformation Manager

EY; Birmingham (AL); Remote; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Pension plan

401(k) plan

Paid time off

Job summary

EY in the United States seeks a Manager in Life Sciences Manufacturing Quality to lead client-facing workstreams transforming quality systems with digital QMS, data and AI across manufacturing and laboratories.

You will coordinate cross-functional teams, translate quality needs into actionable requirements, and drive improvements for audit readiness, data integrity and regulatory compliance in regulated environments.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant 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 working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
• Experience translating quality-domain needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
• Practical understanding of GxP/GMP and the docs, change-control, data-integrity, and electronic-records-and-signatures considerations relevant to digital quality solutions.
• Ability to travel as needed; travel can range from 80-100%.
• Candidates must be legally authorized to work in the U.S. without employer sponsorship.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation, with clear ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits and inspection readiness, supplier quality, and batch disposition.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, document management and informatics systems.
• Define and review data mappings, master-data needs, and data-quality controls for quality reporting and AI use cases.
• Deliver quality analytics and AI use cases by assessing data readiness and governance.
• Ensure GxP/GMP, data-integrity, and electronic-records requirements are reflected in workstream deliverables.
• Oversee testing, readiness, training, cutover support, hypercare and handover for your workstream.
• Facilitate cross-functional sessions and manage scope, schedule, resources, and risks.
• Coach junior team members and capture reusable requirements and design patterns.

Job description

EY in the United States seeks a Manager in Life Sciences Manufacturing Quality to lead client-facing workstreams transforming quality systems with digital QMS, data and AI across manufacturing and laboratories.

You will coordinate cross-functional teams, translate quality needs into actionable requirements, and drive improvements for audit readiness, data integrity and regulatory compliance in regulated environments.