Life Sciences Quality Delivery Manager

EY; Buffalo (NY); On-site; USD 128,000 - 235,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

401(k) plan

Paid time off

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformations across QA/QC, lab operations, and manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while coordinating with quality, IT, and vendor teams.

The role requires turning quality needs into actionable requirements, managing workstreams end-to-end, and delivering measurable improvements in regulated environments.

Qualifications

• A 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 in QA/QC, quality tech, or AI/data.
• Experience leading client-facing quality/digital workstreams through design and deployment.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Ability to translate quality needs into process, data, and testing deliverables.
• GxP/GMP, data integrity, electronic records considerations knowledge; audit-trail understanding.
• Willingness to travel 80-100% as required by business needs.

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, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, and inspections.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems.
• Define data mappings, master data needs, interfaces, and quality reporting controls.
• Help deliver QA analytics and AI use cases with data readiness assessment.
• Work with validation teams to reflect GxP/electronic records requirements in deliverables.
• Oversee testing, deployment readiness, training, and handover for the workstream.
• Facilitate cross-team sessions and manage scope, schedule, and risks.

Skills

Life sciences quality

Client-facing leadership

Quality analytics

Data readiness

Workshop facilitation

Digitally-enabled QA/QMS

Governance & controls

Cross-functional collaboration

Education

Bachelor's degree in life sciences, engineering, quality, supply chain, information systems, business, or related

Tools

eQMS/QMS platforms

LIMS

APIs

Laboratory informatics

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformations across QA/QC, lab operations, and manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while coordinating with quality, IT, and vendor teams.

The role requires turning quality needs into actionable requirements, managing workstreams end-to-end, and delivering measurable improvements in regulated environments.