Lead CSV & Data Integrity Manager (GxP)
Genezen
Genezen in Lexington, MA is seeking a Manager/Sr. Manager, Validation - CSV & Data Integrity to lead the CSV program for GxP systems across lab and manufacturing operations. You will define validation strategies, oversee IQ/OQ/PQ, and drive data integrity practices in collaboration with QA, IT and process owners. The role requires 10+ years of CSV experience, a Bachelor’s degree in Engineering or related field, and deep knowledge of ALCOA+ data lifecycle, regulatory expectations and GAMP 5. #J-18808-Ljbffr
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Lead CSV & Data Integrity Manager (GxP) in Lexington, MA vacancy
$130k - $150k
...proud to be a part of the process that leads to new cures. WORKING AT GENEZEN... ...that team. JOB SUMMARY The Manager/Sr. Manager, Validation - CSV & Data Integrity is responsible for ensuring that computerized systems supporting GxP operations are appropriately...SuggestedContract workLive inWork at officeVisa sponsorshipGenezen
Lexington, MA11 days ago- ...Reference26-00544Job Summary: Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. The role focuses... ...and Serialization platforms. Lead and manage a small team executing CSV activities....Suggested
Katalyst Healthcares & Life Sciences
Waltham, MA1 day ago - ...an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation...Suggested
Katalyst Healthcares & Life Sciences
Somerville, MA5 days ago $121k - $162k
About This Role:We are seeking a Manager, IT Data Integration Lead - Omnichannel & Analytics to serve as the primary bridge between US Commercial business stakeholders and cross-functional IT delivery teams. This role is centered on integrations, with ownership for the...SuggestedFull timeContract workTemporary workLocal areaDay shiftBiogen Idec
Somerville, MA2 days ago$180k - $225k
...Principal Engineer, Enterprise Data Integration Pay: $180 - $225k Base + Bonus + Equity No Sponsorship... ..., data warehouses, master data management systems, and external partner ecosystems... ...operational excellence. Responsibilities Lead the design, implementation, and support...SuggestedHarnham
Boston, MA4 days ago$140k - $182k
...world‑class biologics production facility in Taichung. Position Summary The Global Data & AI Enablement team is seeking an experienced Manager, Data Foundations & Integration to lead data ingestion, integration, governance, and the day‑to‑day operation of the...Temporary workFlexible hours3 days per weekPharmaEssentia U.S.A.
Burlington, MA4 days ago- ...Job Summary We are seeking a Lead CSV / Validation Consultant (Director-Level) for a biotech... ...executing CSV Experience 12+ years in GxP CSV / Validation Strong FDA audit & inspection... ...levels Previous CSV Lead and team management experience is essential #J-18808-Ljbffr...
Katalyst CRO
Watertown, MA4 days ago - ...seeks a Senior Director of IT to build and lead the IT function from the ground up as the... .... You will shape architecture, govern data integrity, and partner with Manufacturing, Quality,... ...and enterprise discipline, with a focus on GxP compliance, security, and scalable...
Terrestrial Bio, Inc.
Woburn, MA1 day ago $110k - $207.5k
Alpha Data Services - State Street Data Integration Delivery Manager - VPPosition location is in Quincy, MA Who we are looking for.We are looking for an experienced... ...life cycle. State Street Alpha is the market leading, first open platform from a single provider that...Full timeTemporary workFlexible hoursState Street Bank
Boston, MA2 days ago- ...(ARS) in Bedford, MA is seeking a Project Scheduler Journeyman with strong Microsoft Project experience to plan, build, and manage the Integrated Master Schedule (IMS) within the PMO. Responsibilities include coordinating IMS activities across disciplines, delivering IMS...
$160k
...A life sciences consulting firm in Waltham is seeking an experienced Manager for their Analytics team. The role focuses on developing data-driven solutions to enhance client business performance in the life sciences sector. Candidates should possess at least 5 years of...Trinity Partners
Waltham, MA5 days ago$230k - $270k
...Senior Director, Data & AI Woburn, MA (on-site/hybrid... ...pipelines we run on, and lead the applied AI work that... ...(e.g., MES, ERP, LIMS), manage how data moves through them, and integrate them into a single coherent... ...control suitable for a GxP-regulated environment...RelocationTerrestrial Bio, Inc.
Woburn, MA2 days ago- Job-ID32471773Reference26-01029Remote50% Remote Responsibilities: Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO...Work at officeRemote work
Katalyst Healthcares & Life Sciences
Boston, MA5 days ago $168k - $252k
...About the RoleWe are seeking a highly technical Lead Product Manager to set the vision, strategy, and execution for our Data Ingestion Platform. This is a platform PM... ...systems. You’ll work closely with engineering, integration teams, and downstream stakeholders to...Temporary workKlaviyo
Boston, MA2 days ago- ...announced positive topline data from our Phase 3 X-TOLE... ...to build a fully integrated, premier neuroscience company... ...The position will help lead the design,... ...warehouse, master data management, clinical and research... ...appropriate controls for GxP, SOX, HIPAA, GDPR, 21 CFR...Temporary workWork at office2 days per week
Xenon Pharmaceuticals
Boston, MA9 hours ago - ...Oracle practice (.)You Are:A senior Oracle Utilities Integration Lead who brings both the architectural vision and the... ...documents (ICDs), integration design specifications, and data mapping artifacts.Establish and manage integration testing strategy and execution,...Work experience placementLive inWork at officeLocal areaRemote work
Accenture
Boston, MA4 days ago $80k - $140k
Business Analyst - Data Integration and ETL, AVPSummary The Business Analyst, AVP will support data integration and ETL capabilities, with... ...as well as new ETL workflows needed to support investment management business processes. Partner with QA to define test scenarios...Full timeTemporary workFlexible hoursState Street Bank
Burlington, MA3 days ago$105k - $115k
...Configuration & CDRL Data ManagerAs a Configuration & CDRL Data Manager, you'll play a key role in maintaining the integrity of mission-critical defense systems throughout the acquisition lifecycle. Working alongside engineering, logistics, and program management teams...Contract workFor contractorsFor subcontractorApplied Research Solutions
Bedford, MA4 days ago$135k - $145k
...Senior Configuration Data ManagerARS is seeking a Senior Configuration Data Manager located at Hanscom AFB, in Bedford, MA.Why Work with us?Applied Research Solutions... ...as a world-class provider of technically integrated solutions as we deliver premier talent and technology...For contractorsFor subcontractorApplied Research Solutions
Bedford, MA5 days ago$165.52k - $265.2k
...and help the world’s leading organizations... ...clients, the technical integrity of what is sold, and... ..., Service Cloud, Data Cloud. • Demonstrated... ..., and risk management. • Working knowledge... ...regulated environments — GxP, 21 CFR Part 11, computer... ...system validation (CSV). • Active...Permanent employmentFull timeLocal areaCapgemini
Burlington, MA4 days ago$120k - $135k
...Senior Configuration Data ManagerApplied Research Solutions is seeking a Senior Configuration Data Manager to provide configuration support and management in accordance with... ...as a world-class provider of technically integrated solutions as we deliver premier talent and...For contractorsNavstar
Bedford, MA5 days ago- ...RTX in Woburn, MA, is seeking an experienced engineer to lead cross-functional performance improvements on complex military systems. You will develop test plans, analyze data, and drive hardware-software integration across multiple locations. Required are a STEM...
Prattwhitney
Woburn, MA5 days ago $115k - $120k
...Data ManagerLOCATION: Hanscom AFB, MASalary Range: $115-$120,000 annually* depending on... ...eligibilityAstrion has an exciting opportunity for a Data Manager providing support to the Command, Control... ...C3BM) has been tasked with delivering an integrated Department of the Air Force (DAF) Battle...Full timeFor contractorsWork at officeASTRION, INC.
Hanscom Air Force Base, MA5 days ago$171.6k - $338.3k
...transformative changes across the data ecosystem in order to compete... ...our next stage of growth. Lead the enablement of governed 3rd... ...the Ascend ecosystem via the integration of our Data Marketplace which... ...technology and vendor team to manage large and prioritized use case...Local areaDeloitte
Boston, MA4 days ago- ...Takeda Pharmaceutical Co. in Cambridge, MA seeks a Resource Utilization & Integration Lead (Senior Manager) to advance GC&G processes, budget governance, and resource optimization. You will partner with HR, Procurement, Legal, and Finance to manage consulting contracts...
Takeda Pharmaceutical Company Ltd
Cambridge, MA5 days ago - ...Systems Specialist to bridge ClinPharm with IT, deploying and validating tools while maintaining GxP compliance. The role emphasizes security, documentation, and risk management within a hybrid USA office setup (EST hours). You will guide tool implementation,...Work at office
Excelra Knowledge Solutions Pvt. Ltd.
Cambridge, MA1 day ago $160k - $185k
Job DescriptionLead Integration Architect, Finance Systems AutomationAbout... ...Workday Integration Architect leads the design, development, and... ...leadership, ensuring seamless data flow and system interoperability... ...:Lead Integration scope: Manage end-to-end integration efforts...Full timeImmediate startRemote workFlexible hoursAcrisure
Boston, MA2 days ago- ...Bayer is seeking a Senior Director, Integrated Product Medical Lead to advance oncology early development programs. You will define vision and strategy across modalities, drive end-to-end product strategies, and collaborate with cross-functional teams to optimize clinical...
Bayer CropScience Limited
Cambridge, MA1 day ago $104.6k
...YOU’LL WORK WITH The Converse Marketing Integration team drives operational excellence across... ...matrixed organization. The Lead Professional reports into Business Integration... ...This person brings exceptional project management expertise, strong organizational discipline...NIKE Retail Services
Boston, MA1 day ago- ...Fenway Health is seeking a Manager of Integrated Behavioral Health and Case Management Services to oversee the clinical and administrative supervision of BH integration specialists and CHWs, while developing an organization-wide case management program with nursing, primary...Temporary work
Fenway Health
Boston, MA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead CSV & Data Integrity Manager (GxP). Be the first to apply!
Related searches
- senior clinical data manager Lexington, MA
- data tech Lexington, MA
- data visualization Lexington, MA
- data loss prevention engineer Lexington, MA
- data loss prevention analyst Lexington, MA
- sap master data Lexington, MA
- data collection Lexington, MA
- test data management Lexington, MA
- data cabling Lexington, MA
- data cabling installation Lexington, MA