21 cfr part 11 jobs in new york

Remote

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Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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12d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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28d ago

Required Skills: 14+ years of SAP QM experience Strong Life Sciences/Pharma/Biotech background SAP S/4HANA experience Expertise in Quality Inspection, Quality Notifications, Batch Management, and QM integration with MM/PP Knowledge of GxP, GMP, and FDA 21 CFR Part 11

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Full-time

Depends on Experience

Senior Infrastructure Engineer

Jersey City, New Jersey

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Today

Senior Infrastructure Engineer The Senior Infrastructure Engineer is a hands-on, technically strong engineer responsible for the day-to-day operation, administration, and continuous improvement of ANI's core IT infrastructure and end-user computing environment. The role spans enterprise networking, Microsoft 365 administration, endpoint and mobile device management, server administration (including backup and recovery), and meeting-room / audio-video technology. A key dimension of this rol

Full-time

USD 50.00 - 60.00 per hour

Equipment Engineer

Summit, New Jersey

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Today

Job Summary: The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment. The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal t

Full-time

Senior Director, Information Technology (BioPharma Industry)

Morristown, New Jersey

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Today

Description The Senior Director, Information Technology will lead enterprise technology strategy, infrastructure, cybersecurity, GxP validation, SOX compliance, and the business application roadmap for a growing late-stage clinical biopharmaceutical organization transitioning toward commercialization. This role will architect scalable technology capabilities, establish practical governance, and align IT with business objectives. The leader will manage a small internal IT team, oversee managed s

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Full-time

USD 210,000.00 - 255,000.00 per year

WME Data Operations Lead – Salesforce Life Sciences Cloud | Pharma : Hybrid - East Brunswick, NJ

Hybrid in East Brunswick, New Jersey

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12d ago

WME Data Operations Lead Salesforce Life Sciences Cloud | Pharma | Patient Engagement :Hybrid - East Brunswick, NJ We are looking to hire a candidate with the skills sets mentioned and experience for one of our clients within the pharmaceutical Industry. This is a Hybrid position. Role Summary This role is critical to designing and implementing the operational controls, monitoring processes, reporting, and issue management framework required to effectively manageWME data operationsfollowing de

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Contract

Depends on Experience

Accenture Edge - Senior SAP Plant Maintenance/Quality Management (PM/QM) Consultant

New York, New York

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Today

We Are: Accenture is a leading global professional services company that helps the world's leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services-creating tangible value at speed and scale. We are a talent and innovation led company with 738,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world's leaders in helping dr

Full-time

USD 73,800.00 per year

SVP of Engineering

New York, New York

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Today

Location: Hybrid, New York Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week in accordance with Company policy. About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers ind

Full-time

USD 252,750.00 - 337,000.00 per year

SAP BRH Functional / Support Lead

Remote

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Today

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Mendix Platform Architect

Remote

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3d ago

Mendix Platform Developer/Architect|| Location Jacksonville, FL Remote || Employment type - contract Job Description: 10 years of software development experience. 5 years of Mendix development experience Experience serving as a solution architect or technical lead. Experience delivering enterprise-scale applications. Technical Skills Mendix Platform Architecture Mendix Studio Pro Microflows and Nanoflows Domain Modeling XPath and OQL Java Actions REST and SOAP APIS SQL Databases Azure

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Third Party, Contract

$65 - $70

Senior Engineering/ IT Program Manager

Remote or Ponce, Ponce

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Today

Job Title: Senior Engineering/ IT Program Manager Client: Medical Device Manufacturing Company Duration: 12 Months Location: 100% Remote (Travel to Ponce, Puerto Rico as needed) Role Overview Lead large cross-functional engineering programs Support manufacturing, digital transformation, and regulated systems Work across Engineering, Manufacturing, Quality, Regulatory, and IT Program Leadership Manage enterprise engineering programs Build roadmaps, milestones, and resource plans Deliver withi

Full-time

Business Application & Systems Administrator

Remote or Boston, Massachusetts

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Today

Job Description The Business Applications & Systems Administrator is responsible for managing, implementing, and optimizing business applications. The role will develop & coordinate testing with impacted departments, including specifically coordinating with IT and Quality for validation & compliance. Manages business application projects, ensuring effective communication across teams/functions as well as informing management of progress and key issues. Key Responsibilities Application Managem

Full-time

USD 116,800.00 - 219,000.00 per year

Senior PLM Windchill Solution Architect

Remote

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5d ago

Position OverviewWe are looking for aSenior PLM Windchill Solution Architectto lead a strategic, customer-facing PLM engagement for a leadingMedical Device / Life Sciences organization.The ideal candidate will be a senior techno-functional architect with strongPTC Windchill PLMexpertise and experience owning end-to-end architecture, technical governance, integrations, migration, validation, AMS, and customer stakeholder management.Key ResponsibilitiesLead end-to-endPTC Windchill PLM solution arc

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Contract

80 - 90

Senior Technical Business Analyst

Remote

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6d ago

DescriptionJob Title: Senior Healthcare Business Analyst Type: Part Time Experience Level: Senior Seeking a highly skilled and experienced Senior Business Analyst responsible for bridging the gap between business objectives and technology solutions, ensuring that our projects align with organizational goals and deliver maximum value. You will utilize your expertise in business analysis and data-driven decision-making to identify opportunities for improvement and drive successful project outcomes

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Part-time

Depends on Experience

Sr SampleManager Implementation Engineer

Remote or Indiana

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior SampleManager LIMS Implementation Engineer How will you make an impact? As a Senior SampleManager LIMS Implementation Engineer, you will be a technical expert responsible for the configuration, implementation, integration, and deployment of Thermo Scientific SampleManager LIMS solutions. This role is highly hands-on and focused on translating defined laboratory processes and solution designs into robus

Full-time

USD 93,800.00 - 140,675.00 per year

Project Manager- Life science industry

Remote

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14d ago

Job Title: Project ManagerLife science industryLocation: Foster City, CA (Fully remote)Duration: FTEEducational Qualification*Any Bachelor''s DegreeExperience Range10 YearsTagline/Tech Stack Snapshot -PM with BA background and experienceRole Summary - (To be filled by Practice /DO)We are seeking a PM and Business Analyst with requirements gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating bu

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Full-time, Third Party

0 - 0

Senior Staff Software Advance Quality Engineer

Remote or Detroit, Michigan

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Today

Work Flexibility: Remote or Hybrid or Onsite It's Time to Join Stryker! Why Join Us In this role, you will help shape software quality practices across a growing portfolio of digital and connected solutions. You will influence how software teams incorporate quality, compliance, security, and risk management into development while establishing scalable processes that support innovation and efficient delivery. Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our

Full-time

USD 102,600.00 - 171,000.00 per year

Associate Director, Biostatistics & AI

Remote

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Today

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitementread on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare dis

Full-time

USD 173,800.00 - 217,000.00 per year

Lead Data Manager/SAS programmer (Job 1425)

Remote

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Today

About Us DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools - including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and sim

Full-time

USD 130,000.00 - 175,000.00 per year

21 cfr part 11 jobs in New York, NY, USA