Life Sciences Quality Transformation Leader

EY

Fort Worth (TX)

Remote

USD 128,000 - 267,000

Full time

8 days ago

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY is seeking a Manager in Life Sciences Manufacturing Quality to lead client-facing, technology-enabled quality transformation across pharmaceutical, biotech, and medical-device clients in a regulated environment.

You will drive design, implementation, testing, adoption, and stabilization of quality systems, with a focus on data integrity, inspection readiness, and AI-enabled quality analytics. A strong mix of domain knowledge and delivery skills is essential.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, or related field.
At least 7 years of Life Sciences Manufacturing Quality, QA/QC, quality-technology, or related experience.
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 documentation, change-control, data-integrity, and electronic-records-and-signatures considerations relevant to digital quality solutions.
Ability to travel as needed based on business and role requirements. Travel can range from 80-100%.
Candidates must be legally authorized to work in the U.S. without the need for employer sponsorship, now and in the future

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation, with clear ownership of plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops, data analysis, and quality and laboratory engagement.
Translate priorities such as right-first-time execution, cycle-time reduction, deviation and nonconformance reduction, CAPA effectiveness, and inspection readiness into process designs, requirements, acceptance criteria, and measurable improvements.
Develop functional designs for relevant quality capabilities such as deviations/nonconformances and investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition/release and review by exception, and quality risk management.
Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and laboratory-instrument and informatics systems, working with architecture, quality-systems, and cybersecurity specialists.
Define and review data mappings, batch and investigation context, master-data needs, interface specifications, and data-quality controls needed for quality reporting, analytics, and AI use cases.
Help deliver quality analytics and AI use cases, such as AI-assisted investigation and root-cause analysis, anomaly and trend detection, predictive quality, and quality decision support, by assessing data readiness, workflow fit, evaluation criteria, and human-in-the-loop review, governance, and controls.
Work with client quality and validation teams to reflect applicable GxP/GMP, data-integrity, electronic-records-and-signatures, controlled-change, and validation or risk-based assurance requirements, including audit trails and traceability, in workstream deliverables.
Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
Facilitate working sessions across quality, QA/QC, manufacturing, laboratory, MS&T, supply chain, IT, data, and technology-vendor teams; expedite decisions and dependencies that affect the broader program.
Manage workstream scope, schedule, resources, quality, and risks; provide clear status updates and contribute to estimates, proposals, and follow-on opportunity shaping.
Coach junior team members, review their work products, and capture reusable requirements, design patterns, and delivery lessons.