gxp Jobs in san francisco, ca

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Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 11 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 32 days ago | Updated 11 hours ago

compliance lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 2 days ago

Assoc. Director, PV Systems Reporting & Analytics

Sunrise Systems, Inc.

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Remote

Contract

Position Title: Assoc. Director, PV Systems Reporting & Analytics Job ID: 25-09090 Location: Remote Duration: 05 months on W2 Contract Top skills: Argus Safety application and drug safety domain knowledge, Computer Systems Validation & SDLC experienceStrong matrix management skills OBJECTIVE: Oversee and support tools used for the reporting and interactive analysis of data from the global pharmacovigilance (PV) databaseProvide technical and strategic input into the roadmap, planning, and imple
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Posted 25 days ago | Updated 1 day ago

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical
Posted 43 days ago | Updated 11 hours ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 35 days ago | Updated 11 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 11 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 57 days ago | Updated 11 hours ago

Kinaxis Rapid Response Consultant

NexInfo Solutions, Inc.

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Remote or Foster City, California, USA

Contract, Third Party

Job Title: Kinaxis Rapid Response Consultant Location: Remote Job Type: Contract Job Summary: We are looking for a skilled Kinaxis Rapid Response Consultant to join our supply chain planning team. The ideal candidate will have hands-on experience with Kinaxis Rapid Response platform, and a strong understanding of supply chain processes including demand planning, supply planning, and scenario modeling.Key Responsibilities: Configure, develop, and deploy solutions using Kinaxis Rapid ResponseCol
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Posted 60+ days ago | Updated 20 hours ago

Oracle Argus Engineer

Spotline

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Alameda, California, USA

Contract, Third Party

Senior Oracle Argus Engineer Alameda CA Onsite role Job Description: Manage implementation/upgrade/support of Oracle Argus Safety System or other Safety solutions and associated interfaces/integrationsPart of technical workstreams (Configuration/Data Migration/Reporting/Upgrade) and provide progress reports, proposals, requirements documentation, and presentations.As Oracle Argus SME, support technical issues associated with Oracle Argus Safety suite and related interfacesHelp deliver project an
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Posted 17 days ago | Updated 10 days ago

Data Engineer with Medical Imaging

Atika Tech

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San Francisco, California, USA

Full-time, Contract

Position: Data Engineer with Medical Imaging Location : San Francisco, CA (4 days on prem at client location) Experience: 10+ years' experience Mandatory Skills: Medical Imaging, Data engineering, Python Key Responsibilities: Imaging Data Pipeline delivery : Design, implement and maintain automated pipelines for onboarding, verifying, transforming and curating biomedical imaging data from clinical trials and real world data sources, for therapeutic areas, Oncology, Neurology, Ophthalmology cove
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Posted 23 days ago | Updated moments ago

SWE - Phython, JavaScript, NoCode, LowCode

Advanced Software Talent

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South San Francisco, California, USA

Contract

Only local San Francisco Bay Area candidates! No 3rd party agencies! Direct W2 contractors only! We are not able to sponsor H1B Visa's. DescriptionJob description: We are looking for a versatile and forward-thinking Engineer to join our team on a contract basis. In this multifaceted role, you will be responsible for designing, developing, and maintaining a variety of software solutions, including low code, custom code, and cloud-based applications. Required competencies include: Bachelor's degre
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Posted 60+ days ago | Updated 22 hours ago

Business Analyst - Data and Analytics

Advanced Software Talent

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South San Francisco, California, USA

Contract

This is a hybrid contract for candidates that are located in Northern California and 100 % remote for candidates outside the area. Direct W2 contractors only! No 3rd party agencies! We are not able to sponsor any H1B Visa! Description BA, Clinical Stage Cell Therapy Process & Analytical Development - Data and Analytics The Business Analyst (BA) is a self-motivated expert in business analysis who is passionate about improving healthcare. They are flexible and dedicated to providing value to patie
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Posted 60+ days ago | Updated 22 hours ago

Pharmacovigilance Business Analyst

Cygnus Professionals

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Remote

Full-time

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and
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Posted 16 days ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 8 days ago

Lead Data Engineer / Lead Data Architect

Bossini Technologies

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Remote

Contract

Job Title: Lead Data Engineer / Lead Data ArchitectLocation: Remote (Preference for US-based candidates)Start Date: ASAP Must have 12+ years of overall IT exp. No OPT or CPT candidates H1B Transfers are encouraged to apply Must be authorized to work in the U.S. without sponsorship (unless H-1B transfer) Job Summary:We are seeking a highly skilled Lead Data Engineer / Lead Data Architect with strong experience in Python and Databricks, preferably with a background in pharmaceuticals or supply cha
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Posted 19 days ago

IRT Auditor

I.T. Solutions

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Remote

Contract

Role: IRT Auditor Location: Remote Type: Contract Length: 6 months Position Summary: We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of AI-driven technologies used in clinical trials. This role is essential to ensuring compliance across oncology programs that leverage artificial intelligence and machine learning (AI/ML) tools for clinical decision support, trial optimization, and real-world data interpretation.
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Posted 5 hours ago

Veeva Promomats Technical Lead - 100% remote

MSquare Systems Inc.

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Remote

Contract, Third Party

We are seeking a seasoned Veeva PromoMats Technical Lead to oversee a high-impact migration project within the life sciences domain, transitioning digital content, metadata, and workflows from legacy systems or DAM platforms into Veeva Vault PromoMats. This role is responsible for leading the technical design, validation, and execution of the migration while ensuring regulatory compliance, content integrity, and operational continuity for commercial and medical review teams. Key Responsibilities
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Posted 59 days ago | Updated 15 days ago

SAP EWM Consultant

Genius Business Solutions

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Remote

Contract, Third Party

Are you a passionate IT trailblazer a growth focused, problem solver who takes full ownership of your work, wants to collaborate & co-create with fellow IT experts, innovate, learn new skills, create new solutions & drive your career to the pinnacle of your potential? If so, you will love working with our Sales Team we are constantly innovating to create breakthrough solutions for our client s growth through a vibrant, fun team culture. Read on below to learn more Featured in CNBC, Digital Journ
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Posted 60+ days ago | Updated 9 days ago