Senior Life Sciences Quality Transformation Manager

EY; Orlando (FL); Remote; USD 128,000 - 267,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory, manufacturing, and supply chain. You will drive quality-system performance, data integrity, and inspection readiness through end-to-end workstreams with pharmaceutical, biotech, and medical-device clients.

The role blends practical quality domain knowledge with digital QMS, data, AI, and delivery skills to deliver value 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 Life Sciences Manufacturing Quality experience.
• Experience leading a client-facing quality/digital/technology workstream.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Translate quality needs into process, data, and testing deliverables.
• Knowledge of GxP/GMP and electronic records/signatures (21 CFR Part 11).
• Ability to travel as needed; travel can range from 80-100%.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
• Assess current-state quality processes, data flows, and site constraints.
• Translate priorities into process designs, requirements, and acceptance criteria.
• Develop functional designs for deviations, CAPA, change control, and audits.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems.
• Define data mappings 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-signatures requirements.
• Oversee configuration, testing, deployment readiness, training, and cutover support.
• Facilitate sessions across quality, manufacturing, IT, and data teams.

Skills

Quality Management

GxP/GMP

Data integrity

AI in quality

Project leadership

Client-facing

Education

Bachelor's degree in Life Sciences/Engineering/Quality

Tools

eQMS/QMS platforms

LIMS

ERP

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory, manufacturing, and supply chain. You will drive quality-system performance, data integrity, and inspection readiness through end-to-end workstreams with pharmaceutical, biotech, and medical-device clients.

The role blends practical quality domain knowledge with digital QMS, data, AI, and delivery skills to deliver value in regulated environments.