Senior CSV Lead - GxP Validation & Compliance (Offshore)
Shrive Technologies LLC
Shrive Technologies LLC is seeking a senior consultant with expert GxP and CSV validation knowledge to support ongoing validation projects. The role emphasizes authoring and reviewing validation deliverables, including compliance plans, user stories, testing, and traceability across the SDLC. The candidate will interact with business partners and technology teams to ensure compliant operation of GxP systems, whether on-prem or cloud, and lead critical conversations to guide regulatory adherence. #J-18808-Ljbffr Shrive Technologies LLC
- ...Roles & Responsibilities: Lead and manage Computer System Validation (CSV) activities across regulated Life Sciences projects. Develop and... ...risk assessments and ensure systems are validated in compliance with GxP requirements. Support validation of GxP...Senior
- ...someone strong with GXP applications, saas/paas... .... In addition to validation and regulation... ...supervison. Strong CSV Expertise, especially... ...; has experience of leading/advising Junior and Senior resources. Specifically... ...etc. Requirements, Compliance/validation Plans,...SeniorRemote work
- ...Position - Lead Architect — Enterprise... ...estate. This is a senior, client-facing role... ...team with an offshore engineering factory... ...bags, and SAP or GxP-validated cookbooks. Set... ...time. Security, compliance and risk Make sure... ...system validation (CSV) for GxP-regulated...OffshoreFull timeLive in2 days per week3 days per week
- ...biotechnology with direct CSV expPractical knowledge of GxP regulations and... ...in leading GxP infrastructure... ...for an offshore resource to support... ...-paced ongoing validation project. Some of... ...this role are -A senior consultant with... ...Proficient in Compliance Plan, User Stories...SeniorOffshore
- ...associates with a strong sense of belonging.Learn more about Inclusion & Diversity at PVH here.bout the Role:The Senior Lead, SAP Security, GRC & Compliance will act as a Subject Matter Expert (SME) for SAP Security & GRC including managing multiple SAP GRC instances, engaging...SeniorFull timeContract workWork at officeLocal area
- Brother International Corporation, headquartered in Bridgewater, NJ, seeks a Senior Manager, Enterprise Compliance (Americas) to lead governance, risk assessments, training, and reporting across the Americas. You will drive policy management and remediation tracking with...Senior
- ...scope alignment, and ongoing validation of deliverables. Capture feedback... ...audience. Collaborate with offshore and onsite teams on product... ...and Vendor Coordination: Leads change projects and works directly... ...The Company is committed to compliance with the Americans with...SeniorOffshoreContract workTemporary workFlexible hours
- ...seeking a CQV Manager in Raritan, NJ to lead Commissioning, Qualification, and Validation for a cGMP cell therapy facility.... ...technical leadership across CQV/CSV programs, audits, and lifecycle... ...management of validated systems, ensuring compliance and quality. In this role, you...
$210k - $256.67k
...implementation together with near-/offshore team membersSparring partner... ...experience in gathering, validating, synthesizing, documenting,... ...influencing skills, especially at senior client levels.Committed to... ...are industry experts that lead complex change agendas driven...SeniorOffshoreFull timeTemporary workWork experience placementRemote work- ...contract We are seeking a Senior Digital Systems Quality Assurance / CSV professional with strong experience supporting GxP computerized systems in... ...with computer system validation, clinical/enterprise... ...Key Responsibilities: Lead/support end-to-end Computer...SeniorFull timeContract work
- ...Senior AWS Integration Developer Location: Raritan, NJ (100% Onsite) Duration: 6 Months+ Role Overview The Senior... ...through active project delivery. Collaborate with Capgemini offshore Platform Engineers to provision AWS services and access for...SeniorOffshore
$220k - $230k
GenScript USA Inc. is hiring a Senior Corporate Legal Counsel (Legal Director) to lead U.S. legal affairs. The role is onsite in Piscataway, NJ, four days a week, with a salary range of $220,000 to $230,000 based on experience. You will review contracts, manage litigation...Senior- ...LEARNING TECHNOLOGIES LLC is seeking a highly experienced Senior SAP SD Analyst to lead OTC processes and SD configuration for a complex... ...expertise and strong project leadership. You will mentor onshore/offshore teams, manage budgets and stakeholders, and drive successful...SeniorOffshoreContract work
- The Residence at Basking Ridge, operated by LCB Senior Living, LLC, is hiring LPNs for a full-time role on our Resident Care team. You... ...residents' health, and participate in documentation and state compliance. The role requires nursing licensure and experience in geriatric...SeniorFull time
$122k - $212.75k
...United States of America Job Description: The Senior Manager, MedTech SCT Surgery Plan Leader, leads the Surgery Planning technology portfolio across... ...business demand across scope, schedule, cost, quality, compliance, and benefits. Manage budgets, estimates, vendors,...SeniorTemporary workWork at officeLocal areaImmediate start- ...advanced electrical and mechanical services on solar, energy storage, and EV charging installations. You will lead and train junior technicians, ensure safety compliance, and complete maintenance tasks to keep equipment operating at peak performance. The role requires strong...Senior
- ...- Computer System Validation- Life SciencesWe are... ...for candidates at Senior Consultants levels... ...System Validation (CSV) within Life Sciences... ...and ensure followed compliance in each release /... ...like 21 CFR Part 11, GxP and GAMP 5.•... ...industry experts that lead complex change agendas...SeniorFull timeTemporary workWork experience placement
- ...Position: GenAI Lead / Architect - Pharma Location: Bridgewater, NJ Experience Profile ● 10+ years of progressive experience... ...transformation projects. ● Proven track record guiding remote or offshore engineering teams while maintaining high project standards...OffshoreFull timeRemote work
- ...Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety - Deliver C&Q... ...and report progress of CQV efforts Documentation & Compliance - Support the generation and review of C&Q procedures for client...SeniorFor contractorsWorldwide
- ...Role Fipsar is seeking an experienced, hands-on Senior Client Engagement & Service Delivery Manager to lead client relationships, service delivery governance,... ...& Analytics managed services. Collaborate with offshore operations leadership and globally distributed L1/...SeniorOffshoreFull timeWork experience placement
$132.23k - $176.31k
...of AI‑ready connectivity, join us today. The Role The Senior Lead Marketing Data Platform Architect is responsible for defining... ...operations, including automated quality controls, monitoring, validation, testing, deployment, and operational intelligence. Partner...SeniorFull timeTemporary work- ...We’re hiring: Business Applications Associate - Senior | Computer System Validation (GxP Systems & AI) A leading biopharmaceutical company is seeking an experienced... ...Associate - Senior to drive Computer System Validation (CSV) deliverables as a key member of the team. You’ll...SeniorFull time
- Johnson & Johnson in Raritan, New Jersey, is seeking a Manager, Business Risk Management to lead risk identification, assessment, mitigation, and governance across Innovative Medicine R&D. You will help implement BRM capabilities, ensure consistent practices, and support...Senior
- Everest Clinical Research is seeking a Senior Talent Acquisition Specialist in Bridgewater, NJ to lead end-to-end recruitment for diverse roles within a fast-growing CRO. You will build strong partnerships with hiring managers, develop proactive talent pipelines, and ensure...Senior
- ...Biotech in Raritan, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs in support of cell therapy... ...manufacturing, and maintenance to meet business objectives while ensuring compliance with cGMP and regulatory expectations. #J-18808-Ljbffr BioNJ Inc...Senior
- US Pharma Lab, Inc. in North Brunswick, NJ is seeking a Senior Manager, R&D to lead multiple product development programs through research, scale-up, and commercialization, ensuring compliance with cGMPs, SOPs, FDA requirements and customer expectations. You will mentor...Senior
- ...Regulatory Affairs team. The role provides senior regulatory oversight for review and... ...promotional materials, ensuring FDA labeling compliance and alignment with company policy. Reporting... ...and Promotion, the incumbent will lead complex promotional reviews, advise on substantiation...Senior
$80 - $92 per hour
...****@*****.***: Engage on CSV Projects as a key team member and drive... ...lifecycle management and remain in a validated state per associated SOPs, regulatory and... ...documents in Veeva *Train, coach, and mentor GxP system owners.Skills: 5-10+ years’ hands...Senior- Nestlé Health Science is seeking a Senior Manager, Advertising, Promotion and Labeling, to own regulatory strategy and governance for promotional and labeling materials across a pharmaceutical portfolio. The role ensures truthful, balanced, and compliant communications...Senior
- ...We are seeking a Senior Business Analyst Veeva... ..., ensuring CSV alignment, and serving... ...and IT teams in a GxP-regulated environment... ...Gather, document, and validate business and functional... .... Plan and lead workshops and interviews... ...Affairs, and Compliance. Align stakeholder...Senior
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