GxP jobs in Massachusetts

Cambridge, Massachusetts

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Today

A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks. Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have devel

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Full-time

$170000 - $190000

IT Project Manager with GxP

Remote

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3d ago

Title: IT Project Manager with GxP Location: Boston MA (1x Month) Duration: 6 Months Visa: No H1b Need an IT/Infrastructure PM with recent Pharma and GXP experience. Must have experience working with MSPs or Vendors Description: The Project Manager will be responsible for the end-to-end project lifecycle of multiple simultaneous IT projects in a GxP regulated environment. The PM will engage in new and in-flight projects to ensure project resources are aligned to deliver on schedule and within

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Full-time

70 - 75

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Lab Computing Analyst

Cambridge, Massachusetts

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13d ago

Lab Analyst/ ONLY W2Introduction: USC/ GCCambridge, MA, 1 in Waltham MA & 1 in Framingham, MA The Lab Analyst position is based in Cambridge, MA and will involve providing consulting, analytical, and technical laboratory services to support various scientific platforms. The individual will work closely with business users and managers to analyze customer needs and propose solutions for the desired state. Responsibilities:Requirements Management and onsite Validation/Compliance supportIT Consulti

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Contract

Depends on Experience

Lead Solution Architect

Remote

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9d ago

Lead Solution Architect Remote (Eastern Time Zone) Location: Remote (must be available to work in the Eastern Time Zone)Travel: Up to 25% travel to client site in North Carolina as needed. About the RoleWe are seeking a highly skilled Enterprise Architect for a Greenfield manufacturing facility project, who will be the site team liaison between IT and business cross functional teams to ensure the quality delivery of 40+ digital capabilities for the new site from an architecture perspective.Key R

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Contract

Depends on Experience

MES Engineer

Norwood, Massachusetts

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19d ago

Position Title: MES Engineer Location: Boston Area (On site in Norwood, MA) Department: Internal DP Operations Systems Regulatory Relevance: GxP Primary System: Apprentice Tempo MES Role Overview: The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization''s Drug Product manufacturing area. This role involves translating manufacturing processes into robust MES solutions, en

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Full-time

50 - 55

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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28d ago

Must Have Technical/Functional Skills :8+ years in IT and Quality Assurance.5+ years supporting Pharma/Life Sciences customers.Experience leading global testing services delivery across US, UK, and India.Strong customer-facing and stakeholder management skills.Test Strategy & GovernanceFunctional, Integration, UAT, and Regression TestingData Testing & ValidationRoles & Responsibilities: Own end-to-end Testing & Validation service delivery across multiple Pharma projects Lead onsite/offshore QA t

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Full-time

110,000 - 130,000

Agilent OpenLAB CDS Analyst

Remote

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Today

Job title: Agilent OpenLAB CDS Analyst Work Location: Rahway, NJ (Remote with Travel) Duration: Long Term Contract Job Description The Senior Technical Analyst will be responsible for supporting configuration, build, validation, & release activities for the successful release of a global enterprise Agilent OpenLAB CDS 2.x platform (OL:CDS), supporting and managing lab deployment resources in Agilent Instrument Controllers (AIC) builds, deployments, & troubleshooting efforts, and oversight of po

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Contract

Depends on Experience

Product Manager - Veeva Vault

Remote

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9d ago

Role: Veeva Vault Product Manager Location: Remote Job Type: FTE/ Full- Time Experience Range: 10- max 22 years Primary Skills: 1. Experience with system integrations (e.g., CTMS eTMF/EDC/Data Lakes & repositories) 2. Experience working with Siebel (CTMS) 3. Experience working with Veeva Managed Services or vendor escalations 4. Familiarity with Agile or DevOps methodologies 5. Knowledge of clinical metrics and reporting tools Required Bachelors degree in Life Sciences, Information Systems, o

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Full-time

Depends on Experience

Veeva Vault Product Manager

Remote

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5d ago

Veeva Vault Product Manager Clinical SME | Remote | FTE Location: Remote Employment: FTE Experience: 1022 Years We are hiring an experienced Veeva Vault Product Manager / Clinical Systems SME with strong expertise in Veeva Vault Clinical (CTMS & eTMF) and clinical trial operations. Key Requirements: 812+ years of experience delivering/leading regulated enterprise or clinical systems initiatives Deep hands-on experience with Veeva Vault Clinical CTMS & eTMF Strong understanding of clinical tria

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Full-time

Depends on Experience

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

•

Today

Job Summary: leading organization is seeking an experienced Pharma IT Testing & Validation Delivery Lead to manage global testing and validation services across multiple Life Sciences programs. Roles & Responsibilities: Own end-to-end testing and validation delivery across multiple pharmaceutical IT projects. Lead onsite and offshore QA teams across the United States, United Kingdom, and India. Define testing strategy, governance, KPIs, delivery standards, and quality metrics. Oversee functional

Full-time

Senior Director, Light-Track Delivery & AI Automation

Remote

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Today

About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate

Full-time

Senior Technical Business Analyst

Remote

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5d 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. Data Architect

Waltham, Massachusetts

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Today

Responsibilities Responsibilities: Design, develop, support, and maintain enterprise data and analytics frameworks and data-related applications to support cross-business functions and domains. Work within regulatory guidelines and industry best practices to drive effective collaboration across information technology and relevant business functions. Work with data modeling techniques such as hierarchical, relational, object oriented, entity-relational, dimensional, and graph, and data principle

Full-time

USD 180,000.00 - 185,000.00 per year

MES Engineer

Massachusetts

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Today

Summary: The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product manufacturing area. This role involves translating manufacturing processes into robust MES solutions, ensuring compliance with GxP standards, and integrating MES with other enterprise systems and automation platforms to streamline operations. Roles & Responsibilities: Assist in the design a

Full-time

Business Application & Systems Administrator

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

Engineering Supervisor, Life Sciences

Boston, Massachusetts

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Today

Why Renovo? Renovo Solutions is a nationwide healthcare technology management company. We offer a range of opportunities for technicians to grow within the company. With a presence in 40+ states, we provide comprehensive solutions for managing & maintaining healthcare technologies. We prioritize investing in our employees' development, offering various phases and advancement paths. Through ongoing training, mentorship programs, and a supportive work environment, we foster professional growth an

Full-time

USD 120,000.00 - 130,000.00 per year

AWS Architect

Boston, Massachusetts

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Today

This scientific AI company is hiring an AWS Cloud Platform Architect. They are looking for someone that has experience designing, building, and managing AWS cloud infrastructure, deployment automation, and ensuring security and compliance across all environments. Must be strong in python and have experience designing and building CICD pipelines. This is a full time position, hybrid 3 days onsite in Cambridge, MA. Required Skills & Experience 7+ years of hands-on experience in DevOps, Platform,

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Full-time

$180000 - $220000

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Waltham, Massachusetts

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Today

Job Description This position provides leadership and accountability for Digital Quality across the organization's Quality, Regulatory, and R&D systems landscape, with responsibility for supporting computer system validation activities in alignment with applicable regulatory expectations, internal procedures, and data integrity requirements. The role is focused on ensuring GxP computerized systems are implemented, maintained, and governed in a compliant, risk-based, and inspection-ready manner

Full-time

USD 110,000.00 - 126,000.00 per year

AI Practice Lead - Life Sciences & Healthcare

Remote

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Today

EPAM AI consulting practice focuses on unlocking business value for organizations through end-to-end AI/ML solutions and platforms. From advanced analytics, marketing intelligence, and NLP to Responsible AI and MLOps, EPAM has delivered hundreds of solutions to production. We are looking for an AI leader to spearhead the initiatives across our Life Sciences and Healthcare Portfolio. This is a role where you will oversee the entire lifecycle of AI solutions, from ideation through delivery and gro

Full-time

GxP jobs in Massachusetts, USA