Global CSV Validation Lead — GxP Compliance & Migration
Katalyst CRO
Katalyst CRO in Raritan, NJ, is seeking an experienced CSV validation professional to lead end-to-end CSV activities in adherence to regulatory standards. The candidate will support business separations for large GxP systems and define risk-based validation strategies. Experience in Pharma or biotech, strong leadership skills, and a comprehensive understanding of FDA regulations are essential for this role. Collaboration with global teams is integral, ensuring compliance with quality standards throughout the validation process. #J-18808-Ljbffr Katalyst CRO
- A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva... ..., with a strong understanding of regulatory compliance. Responsibilities include authoring validation...Suggested
- Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to... ...Validation (CSV) and knowledge of GxP standards. Excellent...Suggested
- ...MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of... ...stakeholder communication, and expertise in GxP compliance documentation. The role also requires...SuggestedRemote work
- ...Validation Lead Raritan, NJ OR New Brunswick, NJ (Onsite – Hybrid... ...separation activities for large global & regional GxP computerized systems with... ...J&J is a huge plus. Strong CSV expertise, especially... ...deliverables (e.g., requirements, compliance/validation plans, test...SuggestedLong term contractWork at officeRemote work3 days per week
- Experienced Validation lead to support end to end validation ownership of... ...management or Business Analysis in GxP application area Act as... ...which includes - Validation / Compliance Plan, Report, RTM, Data Flow... ...and support regarding SDLC and CSV processes, ensuring best...Suggested
- ...Operations Planning. This role involves leading and governing operations planning execution... ...includes working in a dynamic global environment. As part of your responsibilities... ...logistics, and develop teams while ensuring compliance with established standards. This...
- ...Experience in Computer System Validation (CSV) • Experience in... ...(CSV), including Compliance Analysis, Compliance Plan... ...product on time. • GxP experience is required... ...Pharma industries. • Leading the Tech Writer team... ...validation/qualification/migration/verification...
$173k - $299k
...Description Johnson & Johnson is recruiting for a Global Head, IDAR Strategy & Business Operations... ...and portfolio support Communications Compliance & Inspection Readiness Indirect... ...plans, priorities, and measurable outcomes Lead annual planning, goal setting, and...Contract workTemporary workWork at officeLocal area$96.27k - $126.35k
...Legend Biotech is a global biotechnology company dedicated to treating, and one day curing... ...Wed–Sat, 2nd Shift Key Responsibilities Lead and supervise multiple units within the CAR... ...production task to execute and ensure compliance and successful completion of work‑related...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideFlexible hoursShift workDay shiftAfternoon shift$94k - $151.8k
...America Job Description We are searching for the best talent for Global Event Management Coordinator . This hybrid role will be in New... ...management. Corporate Meeting Card (CMC) reconciliation and compliance tracking. Independently reconcile multiple high-value AMEX Corporate...Full timeContract workFor contractorsWork at officeLocal areaImmediate startVisa sponsorship- The Director of Operations will lead and optimize the operational backbone of a mid to... ...client and consultant satisfaction Stronger compliance and risk management controls Reduction... ...Operations, Finance, and Delivery RED Global offers medical, dental, vision, pet, life...Full time
$127.31k - $167.1k
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing... ...of daily production schedules. Lead facility operating review meetings and own... ...unplanned overtime on short notice. GMP compliance and regulatory knowledge: deep understanding...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideAll shiftsMonday to FridayFlexible hoursShift workAfternoon shift$127.31k - $167.1k
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing... ...schedules. This individual will also lead facility operating review meetings and own... ...overtime on little to no prior notice. GMP Compliance & Regulatory Knowledge: Deep...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideAll shiftsMonday to FridayFlexible hoursShift workAfternoon shift- Legend Biotech is seeking a Manager, CMO Operations - VMT Lead (Autologous CAR T) as part of the Global Manufacturing & Supply team based in Raritan, NJ .... ...Proactively identify operational, capacity, and compliance risks; maintain risk registers and mitigation plans....Permanent employmentFull timeContract workFor contractorsLocal area
$255k - $425k
...knowledge in Clinical Supply Operations. Responsibilities include strategic leadership and coordination among global teams, emphasizing robust supply and quality compliance. The position offers a competitive salary range of USD$255,000 - USD$425,000 and requires up to 20%...- ...Piper Companies is currently looking for an experienced ( CQV) Validation Engineer in Raritan, NJ to work for an innovative and growing... ...protocols (IQ/OQ/PQ) for new instruments and ensure compliance with applicable regulations and guidelines. Conduct equipment...
- Legend Biotech, a global leader based in Raritan, New Jersey, is seeking an Operations Manager for the 2nd Shift within its Technical... ...oversee the production of personalized cell therapies, ensuring compliance with cGMP requirements while managing a team and contributing...Afternoon shift
$102k - $177.1k
...Planning is accountable for leading and governing Deliver operations... ...Planning Execution: Lead global execution of Deliver Operations... ...Standards & Playbooks: Ensure compliance with global Deliver planning... ...priorities and tight timelines. Validated ownership of IBP process and...Local areaImmediate start- ..., LLC is seeking a qualified candidate for a role focusing on validation in the pharmaceutical industry. Candidates should have over 3... ...skills, the ability to work as part of a team, and experience leading projects effectively. Familiarity with QA methodologies and the...
- Legend Biotech US is seeking a Validation Specialist to manage and execute site validation activities in compliance with regulatory requirements. The role involves controlling aseptic process validation, implementing changes, and working cross-functionally across technical...
$45k - $50k
...to oversee end-to-end corporate travel booking operations. You will manage both domestic and international travel, ensure policy compliance, and maintain a high level of stakeholder satisfaction. The ideal candidate will have over 2 years of experience in corporate travel...- ...Overview Validation Manager role at WhiteCrow Research. Our client is a global injectables company headquartered in Bengaluru, India, expanding... ...Manager, you will be responsible for leading validation activities, ensuring compliance with regulatory expectations, and maintaining...Full time
$84k - $120k
...team member is welcomed and valued. As a leading global 3PL (third-party logistics)... ...packaging, and transportation to ensure compliance with requirements. Focus on continuous... ...). Co-pack experience. 3PL experience. Valid passport for international travel. #J-1...Temporary workWork at officeMonday to FridayFlexible hours- ...necessary to respond to each work order. # Manages and coordinates compliance with local, state and federal building codes, SDS, OSHA, EPA... ...knowledge of employment laws and company regulations. Valid State Driver's License required for vehicle travel, as needed....Full timeFor contractorsWork at officeLocal area
$110k - $130k
...maintaining high standards of quality, safety, and regulatory compliance with cGMP, SOPs, safety standards, and regulatory requirements... ...Production, Quality, Supply Chain, and Warehouse operational and team leads to oversee daily operational activities to ensure productivity,...Work at officeLocal area$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in... ...Responsibilities Provide quality and compliance oversight for computer... ...applicable standards and global regulations. Interact with Quality... ...a plus. Strong knowledge of GxP compliance. Experience with...Work at officeFlexible hours$133.71k - $162.02k
...responsible for establishing and leading DevOps capabilities that... ...maintaining operational stability and compliance. DevOps & CI/CD Drive... ...testing, deployment, validation, and rollback capabilities.... ...Promote collaboration across global teams and time zones. Qualifications...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...applications and payments, support the Senior Member elevation program, and manage global geo-unit inaugurations, reporting to the Director of Member Operations Administration. You will lead a team of up to eight staff, drive process excellence, vendor relations, and...
$85k - $105k
...escalation owner. Team & Cross‑Functional Leadership: Lead a team delivering complex client engagements;... ..., ops, IT, content. Contract Management: Ensure compliance with contract terms and SOWs; perform volume validations; coordinate invoice approvals; document...Contract workWork at officeRemote work- ...intelligence to power modern businesses globally. We provide a high-growth, fast-paced environment... ...and interview coordination Maintain HR compliance and records Assist with payroll... ...& Cold Calling Conduct cold calling and lead generation Follow up with prospects via...Shift work
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