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Manager, Supply Chain Operations – Life Sciences Manufacturing Quality
EY. Lead client-facing Life Sciences Manufacturing Quality transformation workstreams, owning plans, deliverables, risks, decisions, and outcomes .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Life Sciences Manufacturing Quality, including GxP/GMP compliance, quality process design, and data integrity. Proficient in leading client-facing quality transformation initiatives and integrating quality technology solutions across various systems.
Highest-signal resume keywords
Life Sciences Manufacturing QualityGxP/GMP ComplianceQuality Process DesignEQMS/QMS PlatformsClient-Facing Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality AnalyticsData AnalysisProcess DesignFunctional TestingChange ControlCAPA ManagementQuality Risk ManagementData MappingIntegration RequirementsAI-Assisted Investigation
Soft Skills
Workshop FacilitationStructured Problem-SolvingClient CommunicationTeam CoordinationDelivery Risk Management
Tools & Technologies
LIMSMES/MOMERPLaboratory InformaticsDigital Quality Workflows
Industry Keywords
PharmaceuticalBiotechnologyMedical DeviceQuality AssuranceQuality Control
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Lead client-facing Life Sciences Manufacturing Quality transformation workstreams, owning 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 quality priorities into process designs, requirements, acceptance criteria, and measurable improvements
- Develop functional designs for deviations/nonconformances, investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition/release, and quality risk management
- Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, laboratory-instrument, and informatics systems
- Define and review data mappings, batch and investigation context, master-data needs, interface specifications, and data-quality controls
- Help deliver quality analytics and AI use cases, including AI-assisted investigation and root-cause analysis, anomaly and trend detection, predictive quality, and quality decision support
- Incorporate GxP/GMP, data-integrity, electronic-records-and-signatures, controlled-change, validation, audit-trail, and traceability requirements into deliverables
- Oversee configuration, functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover
- Facilitate working sessions across quality, QA/QC, manufacturing, laboratory, MS&T, supply chain, IT, data, and technology-vendor teams
- Manage scope, schedule, resources, quality, and risks; provide status updates and contribute to estimates, proposals, and follow-on opportunities
- Coach junior team members, review work products, and capture reusable requirements, design patterns, and delivery lessons
Requirements
What you’ll need- 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
- 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 documentation, change-control, data-integrity, and electronic-records-and-signatures considerations
- 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, now and in the future
- Practical understanding of Life Sciences Manufacturing Quality and quality, QA/QC, laboratory, manufacturing, and supply-chain connections
- Ability to translate quality-domain problems into workflows, functional requirements, user stories, data needs, interface requirements, and testable acceptance criteria
- Working knowledge of eQMS/QMS platforms and digital-quality workflows
- Familiarity with LIMS, assays, stability data, OOS/OOT traceability, batch and equipment data, data contextualization, APIs, and laboratory-informatics connectivity patterns
- Sound judgment regarding analytics or AI use, data requirements, controls, and human use of outputs
- Strong workshop facilitation, structured problem-solving, client communication, team coordination, and delivery-risk management skills
Benefits
Comp & perks- Medical and dental coverage
- Pension plan
- 401(k) plan
- Wide range of paid time off options
- Professional growth
- Inclusive culture
- Reasonable accommodation for qualified individuals with disabilities, including veterans with disabilities