Senior CSV Lead - GxP, 21 CFR Part 11, Agile
TechDigital Group
TechDigital Group seeks a senior CSV lead with 10+ years in Computer System Validation and strong GxP background. You will guide regulatory-aligned validation efforts, enforce 21 CFR Part 11 compliance, and drive agile processes using JIRA and X-Ray/qTest. The role requires strong leadership and change-management skills within a regulated environment. The ideal candidate will manage project artifacts, burn charts, and backlog, ensuring quality and compliance across CSV activities in a dynamic #J-18808-Ljbffr TechDigital Group
$94k - $151.8k
...System Validation (CSV) QMS Management and... ...priorities. The Lead Complaints /... ...validation activities for GxP systems/... ...working partnership with senior management Collaborate... ...to CSV including 21 CFR Part 11 Part 210 Part 211... ...highly desirable: Agile SAFe CI/CD RPA Cloud...AgileFull timeWork at officeImmediate start- ...Role - CSV Engineer Location - Raritan, NJ(Hybrid) Job Details... ...in Computer System Validation of GxP systems • Must have experience in Agile methodology and handled multiple releases... ...., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the...AgileWork experience placement
- ...Computer System Validation (CSV) Consultant Share... ...projects implemented using agile methodology •... ...the product on time. • GxP experience is required... ...validation support for 21 CFR Part 11 implementation in Pharma industries. • Leading the Tech Writer team for...Agile
$109k - $174.8k
...Implementation Lead & Project Manager... ...presentation to senior cross-functional... ...System Validation (CSV): Plan and... ...summary reports) for GxP-relevant systems... ...and document Part 11 applicability and... ...knowledge of 21 CFR Part 11 and data... ...Experience with both Agile and waterfall...AgileFull timeLocal areaImmediate startFlexible hours3 days per week- ...and delivering. Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, WICO, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.... ...the executive level required ~ Understanding of Agile methodologies and DevOps concepts preferred. ~...AgileFor contractorsWork experience placement
- ...looking for candidates at Senior Consultants levels who... ...System Validation (CSV) within Life Sciences... ...deploy, monitor) following Agile ways of working and... ...regulations like 21 CFR Part 11, GxP and GAMP 5.• Experience... ...industry experts that lead complex change agendas...SeniorAgileFull timeTemporary workWork experience placement
- ...Description Job Description Be Part of a High-Performing Team... ...based, and emerging AI-enabled GxP applications in a fast-moving... ...Opportunity to work across Quality, CSV, IT, business, and vendor... ...compliance. Apply 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5...SeniorFull time2 days per week1 day per week
- ...Senior Business Analyst – Veeva Vault QualityWe are... ...designing workflows, ensuring CSV alignment, and serving... ...and IT teams in a GxP-regulated environment.Drive... .... Plan and lead workshops and interviews... ...Ensure alignment with GxP, 21 CFR Part 11, and CSV compliance principles...Senior
$109k - $174.8k
...We are searching for the best talent for Senior Business Analyst, R&D Quality to be... .... Apply data integrity, audit trail and 21 CFR Part 11 expectations to data handling and reporting... ...results to senior audiences. Preferred: GxP or quality data exposure. Hands‑on experience...SeniorWork experience placementWork at officeLocal areaImmediate start$120k - $170k
...tracking. Built to support FDA 21 CFR Part 11 and EU GMP Annex 11 Tulip... ...deals. Acronyms like ERP MES GxP eBReDHR LIMS and LES are part... ...drive large complex deals from lead to close. Experience navigating... ...securely and ethically. Required Experience: Senior IC...SeniorFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...Senior CQV Engineer - Commissioning, Qualification & Validation... ...Qualification & Validation) to support a leading cell therapy manufacturing... ...Systems Validation (CSV) exposure Experience... ...therapies. Familiarity with 21 CFR Parts 210, 211, and 1271 ; knowledge...SeniorContract workRelocation
$150k - $258.75k
...The Deployment Leader will be a part of the MedTech Supply Chain... ...closely alongside the Business Lead Technology Lead and Value Stream... ...deployment methodology and agile way of working. Ensure the... ...deliver program presentations for senior-level MD stakeholders....AgileFull timeWork at officeLocal areaImmediate start- ...relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the... ...environment with good understanding of GxP standards and Risk based validation;... ...artifacts (e.g., test scripts). Knowledge of Agile Tools (e.g., Jira, Xray, qTest,...SeniorAgileRemote work
$125k - $130k
...innovative technology to deliver industry-leading digital solutions. Synechron’s progressive... ...workforce of 14,500+, and has 58 offices in 21 countries within key global markets.... ...regulatory requirements. • Experience working in Agile delivery environments. We offer: ~...AgileFull timeTemporary workFlexible hours- Brother International Corporation seeks a Senior Director, Enterprise Program and Change Management to lead enterprise PMO and organizational change initiatives across... ..., governance and change management, with PMP/Agile preferred and a hybrid work setup #J-18808-Ljbffr...SeniorAgile
- ...ROLE_DESCRIPTION: Deep understanding of Agile principles and practices| including Scrum| Kanban| and Lean. Ensure the... ...product on time. Scrum Master certification is preferred. GxP experience is required Experience in Life Sciences CPG...AgileFlexible hours3 days per week
$155.29k - $287.57k
...grow with us. If you want to be part of an inclusive, adaptable,... ...a high-performing enterprise Senior Sales Specialist to drive new... ...transform legacy technology into agile, AI-powered business platforms... ...exceeding annual quota. Lead strategic account planning and...SeniorAgileContract workTemporary workWork at officeRemote workWork from homeHome officeFlexible hours$21 per hour
...Security Officer Part Time Unarmed Patrol As a Security Officer... ...Petrochemical, and more. Join a leading team where flexibility meets opportunity... .... Join Allied Universal's agile, reliable, and innovative team,... ...Type: Part Time Pay Rate: $21.00 / Hour Job Schedule:...AgilePart timeFor contractorsLocal areaShift work- Johnson & Johnson is seeking a WW Senior Inventory Manager to lead global inventory planning and drive optimal stock levels across regions. The role partners with regional planning, supply network planning, product planning and logistics to ensure commitments are met....Senior
$117k - $201.25k
...equity and inclusion. The Senior Software Engineer will be... ...-assisted workflow automation Agile SCRUM Reliability & Security.... ...experience is required. Experience leading agile software development... ...required. Experience with GxP software development is preferred...SeniorAgileFull timeTemporary workLocal areaImmediate start- Johnson & Johnson's IDAR division seeks a Manager, Regulatory Medical Writing to oversee the preparation and finalization of clinical documents across key therapeutic areas. This hybrid role requires guiding processes, mentoring teams, and participating in cross-functional...SeniorRemote job3 days per week
- ...Senior Manager, Customer Success Ethicon, a member of the Johnson & Johnson family of companies... ...will serve as the primary relationship lead for assigned areas, crafting high-value... ...digital portfolio. Certification or training in Agile, Product Management, Change Management,...SeniorAgileWork experience placementLocal area
- Johnson & Johnson is seeking a Senior Business Analyst, R&D Quality, to join our QA function within RDQ. The role partners with process owners to translate business needs into analytics, dashboards, and quality solutions that improve compliance and decision-making. Expect...Senior
- ...OQ/PQ, Traceability Matrix, Reports, SOPs) Ensure compliance with GxP, FDA regulations, and risk-based validation Support Acquisitions,... ...: 7-10+ years of experience in Computer System Validation (CSV) Experience in Pharmaceutical / Biotechnology / Medical Device industry
$119k - $149k
...Senior Project ManagerEverest Global Services, Inc. is seeking a Senior... ...a fast-paced environment and leads by example through... ...project management tools and Agile delivery methodologies preferred... ...of our culture and an integral part of how we work: Talent. Thoughtful...SeniorAgile$40 - $55 per hour
...Vaco has a client near Bridgewater NJ looking for a part time Family Office Accountant to work onsite and be responsible for the accounting related to the owner's personal finances, trusts and investments, as well as some real estate holdings. Do not pass up this chance...SeniorPart timeFor contractorsWork at officeLocal area$160k - $180k
Description:The Senior Manager, IT Application Support will lead and oversee all aspects of global... ...industry compliance (FDA, SOX, GxP), with the ability to... ...or to participate in any part of the hiring process,... ...with DevOps practices and agile methodologiesBackground in...SeniorAgilePermanent employmentTemporary workLocal areaFlexible hoursShift work- ...PTC Therapeutics seeks a Senior Manager of Clinical Data Management to oversee data integrity... ...aging, and data quality metrics Lead vendor interactions and contribute to... ...Medidata RAVE Knowledge of ICH guidelines, 21 CFR Part 11, and FDA regulatory requirements...SeniorWork at office
$125k - $130k
...innovative technology to deliver industry-leading digital solutions. Synechron’s progressive... ...workforce of 14,500+, and has 58 offices in 21 countries within key global markets. \n... .... \n • Experience working in Agile delivery environments. \n \n We offer...AgileTemporary workFlexible hours$196k - $342.7k
...finding treatments and cures. We lead where medicine is going and... ...step of the way. Learn more at Senior Global Medical Affairs Leader... ...compound focused GMALs being part of the cross-functional 3M (medical... ...environment demonstrating agility and resilience under pressure....SeniorFull timeTemporary workLocal areaWorldwide
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