21 CFR Part 11 jobs in Philadephia, PA

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

Remote

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Yesterday

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

ML Platform Engineer

Remote or New York, New York

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28d ago

Role OverviewThis role will help enable algorithm development, model packaging, model registration, reproducible execution, and governed deployment workflows across imaging datasets, Integrated Data Products, and Analysis-Ready Datasets. The role is focused on ML platform engineering, MLOps, model integration, and validation readiness rather than developing new clinical interpretation algorithms. Key ResponsibilitiesBuild and support ML / MLOps capabilities within the Global Imaging Platform.Int

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Contract

Depends on Experience

SAP Batch Release Hub (BRH) SME

Philadelphia, Pennsylvania

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Today

job summary: We are seeking a Senior SAP Batch Release Hub (BRH) Subject Matter Expert to drive solution sustainment, production support, and regulatory compliance for global Life Sciences operations. In this role, you will lead L2 support, incident management, and system integrations between SAP S/4HANA QM and key manufacturing platforms. You will play a pivotal role in ensuring smooth go-live transitions, hypercare execution, and overall operational efficiency in a highly regulated environmen

Contract

USD67 - USD77

Veeva Vault Regulatory Business Analyst

Trenton, New Jersey

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Yesterday

Job Title: Veeva Vault Regulatory Business Analyst Location: Ewing, NJ Hybrid (3 Days Onsite / Week) Job Summary We are seeking an experienced Technical Business Analyst / Product Owner to support the strategy, roadmap, and delivery of digital solutions across Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes within a highly regulated global R&D environment. The ideal candidate will have strong hands-on experience with Veeva Vault Regulatory

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Contract, Third Party

Depends on Experience

Sr. CSV Engineer

Chesterbrook, Pennsylvania

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Today

Job Summary: Seeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments. The ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management. Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required. Roles & Res

Full-time

PASX Support engineer

Remote

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21d ago

Bachelor's degree in Engineering, Computer Science, Information Systems, or equivalent practical experience. Proven hands-on experience configuring and maintaining Werum PAS X (MES) in pharmaceutical or biotech manufacturing environments. Strong understanding of pharmaceutical GMP, electronic batch records, and computerized system validation (CSV), including IQ/OQ/PQ documentation. Practical knowledge of MES concepts and standards (ISA 88, ISA 95) and how they map to PAS X configuration. Experie

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Contract

Depends on Experience

Business Application & Systems Administrator

Remote or Carpinteria, California

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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 93,760.00 - 175,800.00 per year

Release Manager- Entry Level

Remote

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8d ago

Role Summary We are hiring a Release Manager based in either the APAC or EMEA region to coordinate the endtoend release lifecycle for a portfolio of enterprise and product facing applications. You will partner across engineering, QA, infrastructure, security, and business stakeholders to ensure that every release is predictable, auditable, and customer safe. This is a hands on role focused on running the release cadence reliably, improving CI CD and change processes incrementally, and providing

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Full-time

$60,000 - $80,000

SAP ATTP Techno-Functional Consultant

Remote

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20d ago

Employment type Contract Job Title SAP ATTP Techno-Functional Consultant Job Location Remote, Occasional Travel to Foster City, CA Duration 6 months Experience level L3 Mandatory Skills Job Description o Lead functional design, implementation, and optimization for ATTP-related programs and initiatives o Collaborate with business stakeholders & external partners (3PL, CMOs) to gather, analyze, and document functional requirements. Identify AS-IS process and design T

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Contract, Third Party

Depends on Experience

Project Manager- Life science industry

Remote

•

Yesterday

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

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Product Owner (PLM, QMS & Regulatory)

Remote

•

Yesterday

Veeva Regulatory One (ONLY W2/ UCS)Technical Product Owner, PLM, QMS & Regulatory Position Summary: The Technical Product Owner, PLM, QMS & Regulatory will own and evolve the digital and AI product capabilities that support product lifecycle management, quality management, and regulatory business processes across global R&D. This role will combine product ownership with strong business analysis responsibilities, ensuring that business needs are translated into clear requirements, prioritized bac

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Contract

Depends on Experience

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

•

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

Business Analyst, AI & Enterprise Data Products

Remote

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11d ago

Business Analyst, AI & Enterprise Data Products Duration: 12+ Months Location: Remote Work Authorization: USC Position Summary We are seeking a Business Analyst to define requirements for an AI-driven application serving internal business functions across Quality / Manufacturing / Clinical / Regulatory / Commercial. The application sits on top of a substantial data layer, drawing from multiple enterprise source systems, and uses machine learning for surface insights / generate draft content /

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Contract

55 - 60

Lead Software Platform Engineer, MLOps

Remote

•

Today

Who We Are TetraScience is the Scientific Data and AI Cloud company. We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes. TetraScience is the category leader in this vital new market, generating more revenue than all other companies in the aggregate. In the last year alone, the world's dominant players in

Full-time

USD 200,000.00 - 270,000.00 per year

SAP Delivery Manager (ERP) Life Sciences

Remote

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15d ago

SAP Delivery Manager (ERP) Life Sciences Devfi, Inc. 100% remote Salary: DOE About Devfi Devfi, Inc is an SAP services partner to life sciences and pharmaceutical companies. We deliver S/4HANA implementations for global pharma manufacturers, CDMOs, biotech and medical device clients across the Globe. Our clients operate under FDA, EMA and MHRA,GxP oversight. Every system we touch is validated and every change is auditable that standard is why they choose a specialist partner over a generalist.

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Contract

Depends on Experience

SAP Principal Architect, Transportation Management

Remote

•

Today

Career Category Information Systems Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of pati

Full-time

USD 167,720.30 - 226,915.70 per year

Staff Enterprise Applications Developer - IBM Maximo

Remote or San Diego, California

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Today

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insig

Full-time

USD 116,600.00 - 194,400.00 per year

Business Architect, Applied AI & Automation

Remote

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Today

Full-time

USD 120,677.05 - 163,268.95 per year

Global Automation Engineering & Technology Head

King of Prussia, Pennsylvania

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Today

Position Purpose: The Global Automation Engineering & Technology Head is accountable for defining and executing the enterprise strategy for GxP manufacturing and laboratory digital systems, including PCS, MES, OT Data Systems, and LIMS platforms. This role provides global lifecycle ownership, governance, and standards for platforms, data, and recipes across manufacturing and QC laboratories, ensuring harmonized, compliant, and future-ready operations. Acting as a Center of Excellence, the posit

Full-time

21 CFR Part 11 jobs in Philadelphia, PA, USA