- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study oversight and execution.Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure ... measures in place to course correct where needed. The Director will be accountable to support SDL and employee...reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure proactive representation of ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...during inspections and external audits. Ensure ongoing submission and inspection readiness for the respective Medical Affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sites. In addition, this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance ... landscape to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...a global and regional level as required.Support audit and inspection readiness activities as a subject matter… more
- Merck & Co. (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
- Merck & Co. (Rahway, NJ)
- …compliance and operational excellence in the laboratories. Maintains a state of inspection readiness . Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Merck & Co. (Rahway, NJ)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical IndustryPreferred Skills: ... Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and… more
- J&J Family of Companies (New Brunswick, NJ)
- …Johnson & Johnson is currently recruiting for a IM PD Asset Management Readiness Lead! This position can be located in New Brunswick, Titusville or Raritan, ... and patients._ The Innovative Medicine (IM) Project Delivery (PD) Asset Management Readiness is part of the Project Delivery Technical Support Group (TSG), that… more
- Merck (Rahway, NJ)
- …and operational excellence in the laboratories. + Maintains a state of inspection readiness . + Performs proactive resourcing planning and risk assessment ... Communication, Decision Making, Dosage Forms, GMP Compliance, Immunochemistry, Innovation, Inspection Readiness , Learning New Concepts, Manufacturing, Microbiological… more
- Taiho Oncology (Princeton, NJ)
- …Deviations, Corrective Actions and Preventive Actions (CAPAs). + Responsible for supporting inspection readiness related to GVP. + Support Taiho Global GXP ... Pharmaceuticals Co., Japan, TCAN. TPOC, and TPAC as needed. + Support inspection readiness activities including audits and inspections conducted by external… more
- Bristol Myers Squibb (Madison, NJ)
- …manage regulatory inspections, applying principles of Quality Risk Management to ensure inspection readiness and compliance. Assist in the review and preparation ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Quality Compliance, is responsible for ensuring robust… more
- Merck (Rahway, NJ)
- …FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, Inspection Readiness , Pharmaceutical Development, Pharmaceutical Industry **Preferred ... **Job Description** ** Director - Global Quality Auditing and Supplier Management** The Director will report to the Animal Health Global Quality Lead for… more
- Bristol Myers Squibb (Madison, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Cell Therapy Quality Automation Services will report to the ... Executive Director of Cell Therapy Global Product Quality and serve...highest standards of cGMP compliance, product quality, and regulatory readiness as BMS automates Cell Therapy manufacturing, testing and… more
- Sysco (Rahway, NJ)
- …a high-performing quality culture across the organization. **POSITION PURPOSE:** The Director of Global Quality Assurance & Quality Control leads the quality ... systems, CAPA processes, risk management programs, change controls, and audit readiness frameworks. Lead internal and external audit programs and ensure … more
- System One (Basking Ridge, NJ)
- …Expert (SME) for safety surveillance and risk management for assigned product(s), through inspection readiness preparation, and may serve as the primary or ... Job Title : Associate Director , Clinical Safety Scientist (Contingent Worker) Job Schedule: Candidate can work 100% remote - preference would be EST/CST based… more
- Merck (Rahway, NJ)
- …and execution of design verification strategies, and design transfers for testing readiness , which includes incoming and release tests for components and combination ... employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of… more
- J&J Family of Companies (Raritan, NJ)
- …to meet the portfolio objectives throughout the year. + Support regulatory inspection readiness , inspections, and CAPAs where relevant **Education and ... America **Job Description:** Johnson & Johnson, is recruiting for a Executive Director , Therapeutic Area Safety Head, Cardiopulmonary to be located in Raritan, NJ;… more
- City of New York (New York, NY)
- …regulations. You will oversee vendor performance, conduct field audits, review inspection reports, and provide technical guidance to staff. Working closely with ... healthy housing for New Yorkers while streamlining processes across Co-op Readiness , Property Management, and Asset Management divisions. Your Responsibilities: -… more
- Taiho Oncology (Princeton, NJ)
- …process throughout TOI/TPC Medical affairs and implement training enterprise wide + Lead inspection and audit readiness plan and process for Medical Affairs. ... & D, Legal Compliance, Quality, Finance, IT. Direct reports include: Sr. Director Scientific Communications, Director Medical Information, Director Business… more
- Immigration and Customs Enforcement (Elizabeth, NJ)
- …applicable policies, accreditation standards, laws, and regulations. Collaborates with the Clinical Director and Nurse Manager, as a function of the Triad of ... disposal services, air management services, medical and dental equipment inspection and recalibration services, radiology services. Monitors on-site contracts to… more
