Life Sciences Quality Transformation Manager

EY; City of Albany (NY); On-site; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Job summary

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across pharmaceutical, biotech, and medical-device manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while aligning with QA/QC, laboratory, and manufacturing teams.

You will coordinate with architecture, cybersecurity, and quality-systems experts to deliver design, testing, and deployment of improvements, including AI-enabled quality analytics and

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 a 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.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for quality capabilities (deviations, CAPA, change control, audits, inspection readiness).
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems.

Skills

Quality leadership

Client facing

Digital QMS

Data analytics

AI in quality

Workshop facilitation

Education

Bachelor’s degree in life sciences or related

Tools

eQMS/QMS platforms

LIMS

APIs

Job description

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across pharmaceutical, biotech, and medical-device manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while aligning with QA/QC, laboratory, and manufacturing teams.

You will coordinate with architecture, cybersecurity, and quality-systems experts to deliver design, testing, and deployment of improvements, including AI-enabled quality analytics and