GXP Jobs in Boston, MA

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Global IT Compliance Sr Specialist

Thermo Fisher Scientific

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Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 15 days ago | Updated 6 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 11 days ago | Updated 6 hours ago

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 6 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 27 days ago | Updated 6 hours 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 19 days ago | Updated 3 days ago

Senior Director, Head of Research Systems Engineering

Johnson & Johnson

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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
Posted 9 days ago | Updated 6 hours 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 38 days ago | Updated 6 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 30 days ago | Updated 6 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 6 hours ago

Principal Software Engineer

Amgen Inc

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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
Posted 10 days ago | Updated 6 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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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
Posted 16 days ago | Updated 6 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 52 days ago | Updated 6 hours ago

Project Manager

Maverick Technology Partners

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Andover, Massachusetts, USA

Contract

Project Manager - 5-6 Month Contract - Hybrid North of Boston NO C2C - Must be able to work without sponsorship High Priority project working with multiple internal and external groups within IT and the businessData Integration Project with clients supplied to implement software upgrade. - Need to finish the upgrade and build into their process (which is manual)Knowledge of GXP, Validation, Pharma is a MUSTAgile/Scrum environmentStrong communication skills Nice to Haves: Snowflake is a plus and
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Posted 25 days ago | Updated 3 hours ago

IT Support Specialist (PC , Mobile & BioPharma Environment- MUST)_Lexington/Cambridge, MA (Onsite)

Xoriant Corporation

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Lexington, Massachusetts, USA

Contract

Xoriant is an equal opportunity employer. No person shall be excluded from consideration for employment because of race, ethnicity, religion, caste, gender, gender identity, sexual orientation, marital status, national origin, age, disability or veteran status. JOB TITLE : IT Support Specialist Bio Pharma Environment LOCATION: Lexington/Cambridge, MA (onsite) TYPE: Contract (1+Yrs) RATE : $40 per hour on W2 (Without Benefits) JOB DESCRIPTION: Top 3 Must-Have Skills:PC & Mobile Device Support M
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Posted 10 days ago | Updated 5 days ago

CRM Solution Architect, Patient Support Services

SGS Consulting

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Cambridge, Massachusetts, USA

Contract

Title: CRM Solution Architect, Patient Support Services Location: Morristown, NJ or Cambridge, MA (Hybrid, 3 day s onsite) Job Duration: 12 Months (Contract, possibilities of extension) Description: We are seeking a skilled, hands-on Salesforce Solution Architect to join our team. As part of the Patient Services Solution Architecture team, you will lead the design and implementation of comprehensive cutting-edge solutions that deliver best-in-class patient experience, enhance operational effici
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Posted 12 days ago

SAP Principal Solution Architect

Stefanini

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Danvers, Massachusetts, USA

Contract

About the Role: We are looking for an experienced and driven ERP Platform Product Analyst to join our Heart Recovery IT. In this high-impact role, you will act as the right hand to the ERP Platform Owner, helping to lead and evolve our SAP S/4HANA platform in support of Supply Chain and Finance operations. You'll help shape long-term ERP strategy while ensuring seamless execution of day-to-day operations in a business growing double digits and saving lives every day. Key Responsibilities:Collabo
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Posted 51 days ago | Updated 1 hour 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 10 days ago

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

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Remote

Third Party, Contract

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra
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Posted 3 days ago

SAP OTC Solution Architect

NexInfo Solutions, Inc.

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Remote

Third Party, Contract

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
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Posted 9 days ago

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

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Remote or King of Prussia, Pennsylvania, USA

Contract, Third Party

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato
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Posted 4 days ago | Updated 3 days ago