Location: Anywhere in Country
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Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams that strengthen quality systems, compliance, audit and inspection readiness, and product quality across manufacturing and laboratory operations. The role combines practical quality-domain knowledge with digital QMS, data, AI, and delivery skills to turn quality needs into solutions that work in regulated environments.
The opportunity
As a Manager in Supply Chain Manufacturing Quality, you will work with pharmaceutical, biotechnology, and medical-device manufacturers to improve how quality, QA/QC, laboratory, manufacturing, and technology teams operate together. You will lead defined workstreams from assessment and requirements through solution design, implementation, testing, adoption, and stabilization, with a focus on quality-system performance, data integrity, and inspection readiness.
This is a techno-functional delivery role. You will facilitate decisions with client quality and laboratory teams, translate quality and lab needs into actionable requirements, coordinate functional and technical specialists, and take ownership of the quality and progress of your workstream. You will contribute to broader program planning and value realization while working with senior engagement leaders on cross-program decisions and commercial matters.
Your key responsibilities
In this role, you will:
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; escalate 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.
Skills and attributes for success
You will bring:
Practical understanding of Life Sciences Manufacturing Quality and the connections among quality, QA/QC, laboratory operations, manufacturing, and supply chain.
The ability to turn quality-domain problems into clear workflows, functional requirements, user stories, data needs, interface requirements, and testable acceptance criteria.
Working knowledge of eQMS/QMS platforms and digital-quality workflows, with enough technical fluency to collaborate effectively with quality-systems specialists, architects, data engineers, developers, and cybersecurity teams.
Familiarity with LIMS, assays, stability data, OOS/OOT traceability, batch and equipment data, data @contextualization, APIs, and laboratory-informatics connectivity patterns relevant to the solution being delivered.
Sound judgment about when analytics or AI is useful, what data and controls it requires, and how people will use its outputs in quality or laboratory workflows.
Strong workshop facilitation, structured problem-solving, client communication, team coordination, and delivery-risk management skills.
To qualify for the role, you must have:
A 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 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
Ideally, you'll also have:
Experience with drug substance, drug product, biologics, sterile manufacturing, medical devices, or clinical-to-commercial scale-up quality processes.
Delivery experience with eQMS/QMS platforms, LIMS, electronic batch records, connected-worker tools, quality analytics, or manufacturing/quality data platforms.
Familiarity with quality risk management frameworks (e.g., ICH Q9), audit-trail and traceability requirements, and electronic-records-and-signatures standards (e.g., 21 CFR Part 11) as relevant to client systems.
Awareness of data-integrity practices and controls relevant to GxP laboratory and quality systems.
Familiarity with quality analytics and continuous-improvement practices, including the use of quality, laboratory, and process data to monitor performance, identify recurring events, and support root-cause analysis.
Experience supporting computer system validation or risk-based computer software assurance where applicable to the regulated product and system.
Experience with multi-site deployments, quality-system harmonization, technology transfer, or the development of reusable solution assets.
A relevant program-management, quality, cloud, data, or manufacturing-technology certification.
What we look for
We are looking for a Manager who is comfortable with quality and laboratory realities and capable of leading a mixed functional and technical team through implementation. The successful candidate will build trust with client counterparts, produce clear and usable delivery artifacts, recognize quality and technology risks early, and help turn digital QMS and AI investments into sustainable quality improvements.
What we offer you
At EY, we harness our collective strength to empower you to shape your future with confidence through professional growth, personal fulfillment and an inclusive culture. Learn more at ey.com/us/careers .
The salary range for this job is:
New York City, Boston, and Washington DC Metro Areas, Washington State, and Southern California offices - $154,000 to $256,700
Bay Area California offices - $160,500 to $267,400
All other offices locations in the US, including Sacramento - $128,400 to $235,300
Individual salaries within these ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.
Are you ready to shape your future with confidence? Apply today.
To make the most of your application experience, please limit yourself to two applications within a six-month period.
EY accepts applications for this position on an on-going basis.
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