GxP Jobs in New Jersey

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Senior Director, Head of Research Systems Engineering

Johnson & Johnson

Remote or Pennsylvania, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

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

Veeva Promo Mats Technical Architect-W2

Narvee Tech Inc

Remote

Contract

Job Title: Veeva Promo Mats Technical Architect Duration: 12 Months (Possible Extension) Location: Remote/Hybrid Client Note: Minimum 2-3 end-to-end implementation required on Promo Mats.We are looking who have extensive experience in PROMOMATS. Only ask those who are hands-on with the projects who can describe the details of the project. Need Promo Mats expertiseJob Description Join IBM's Veeva Practice team as an Architect & Engineer for Veeva Commercial Cloud, where you will be a key leader i

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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

Principal Software Engineer

Amgen Inc

Remote or Thousand Oaks, California, USA

Full-time

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

Senior Manager, Data Analytics

Quest Diagnostics Inc.

Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi

External Manufacturing and Supply - Specialty Care Large Molecule Site Operations Lead

Sanofi

Morristown, New Jersey, USA

Full-time

Job DescriptionJob Title: External Manufacturing and Supply - Specialty Care Large Molecule Site Operations Lead Location: Remote, St. Louis, Missouri About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Reporting to External Manuf

Technical Architect-Salesforce

IBM

Princeton, New Jersey, USA

Full-time

Introduction Salesforce Technical Architect - Techno-functional Salesforce expert who demonstrates expertise in Salesforce Health and Life Science Industry Clouds. Your role and responsibilities Demonstrates expertise in Salesforce Health and Life Science Industry Clouds. Has overall responsibility, oversight, governance and ownership of the technical solution. Oversees and advises on technical challenges presented to the project team and also advises on how to best leverage Out-of-Box function

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

Remote or Foster City, 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

Capital Projects IT/OT Compliance Sr. Specialist (Hybrid - West Point, PA)

Merck & Company Inc

Remote or West Point, Pennsylvania, USA

Full-time

Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation. The senior specialist, Digital Foundational Services, IT / OT Compliance role is charged with the administration of regulatory compliance programs, demonstrates adherence to policies and procedures, championing continuou

Lead, Regulatory Data

Sanofi U.S.

Morristown, New Jersey, USA

Full-time

Job Title: Lead, Regulatory Data Location: Cambridge, MA, Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Lead, Regulatory Data is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical a

Software Developer for Lab Informatics/ Life Science Platforms - San Diego

Accenture LLP

San Diego, California, USA

Full-time

A Software Developer for Lab Informatics/ Life Science Platforms Location: Sand Diego, resource will be 100% onsite at client, acting as the interface between the site's stakeholders and the Accenture global support team. This resource needs to have strong communication / client facing skills and will serve as main point of contact and act in a liaison capacity to facilitate problem resolution, communicating between IT teams and other departments as required. This resource needs to have flexibil

Kinaxis Rapid Response Consultant

NexInfo Solutions, Inc.

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

Pharmacovigilance Business Analyst

Cygnus Professionals

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

Lead IT Validation Consultant

Amaze Systems Inc

New York, USA

Contract, Third Party

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

Veeva Systems Developer

Avtech Solutions

Arkansas, USA

Contract, Third Party

Job title: Veeva Systems Developer Location: Remote Duration: 1 Year Contract description We are seeking a Veeva System Developer - Contractor to provide subject matter expertise Collaborate on the design and lead the implementation of Enterprise Applications solutions tailored to specific business applications or technologies, aligning with enterprise business strategy and requirements. Administer, configure, and optimize Veeva Vault PromoMats to support the Quality Management System (QMS).

SAP OTC Solution Architect

NexInfo Solutions, Inc.

Remote

Contract, Third Party

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges

Remote Veeva Clinical Business Analyst

Dale Workforce Solutions

Remote or Princeton, New Jersey, USA

Contract

Analysts for Veeva Vault implementations help guide our clients in the configuration and deployment of Veeva s cloud-based solutions, ensuring successful outcomes for any and all aspects of the project. A successful analyst should be well-versed in translating design documents into functional specifications, mapping business processes for technical solutions, and documenting business requirements for the core application, system integrations, and legacy data/document migrations. The analyst is a

MS Dynamics Platform Product Lead / Integration Tech Lead

ARMO Consultants

Parsippany-Troy Hills, New Jersey, USA

Full-time

About the Role:We are seeking a senior-level Tech Lead with deep expertise in Microsoft Dynamics 365 and the Power Platform to lead the design, development, and integration of enterprise-grade solutions across our pharmaceutical business units. This role combines product ownership, technical leadership, and hands-on development, with a strong focus on automation, compliance, and scalability.Key Responsibilities:Lead architecture, development, and integration of Microsoft Dynamics 365 (CE, F&O) a