- 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)
- …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)
- …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
- 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
- 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
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Inspection Readiness is responsible for ensuring ... cell therapy, and medical device operations. Reporting to the Senior Director of Inspection Readiness , this individual contributor role leverages extensive… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …activities, in partnership with risk program and SMEs. + Support the overall inspection readiness of the GVP Audit program, including preparation for and ... Join Gilead and help create possible, together. **Job Description** The Associate Director , Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within… 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Executive Director , Combination Product Development** **Overview** The Executive Director ... + Provide strategic oversight for late-stage development and commercialization readiness , ensuring robust risk-based decision-making and alignment with global launch… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …as assigned. Holistically identify and assess GPS operational risks, supporting inspection readiness in collaboration with team stakeholders and relevant ... Regeneron's Global Patient Safety Organization is looking for a Director , PV Enablement to join the team!! **In this...this role, a typical day might include:** + The Director of PV Enablement will report directly to the… 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
- IQVIA (Parsippany, NJ)
- …+ Ensure real-time tracking and documentation of trial progress. + Maintain inspection - readiness throughout the trial lifecycle. + Act as the primary ... Overview:** IQVIA is seeking an experienced Associate Clinical Project Management Director /Trial Delivery Manager (TDM) to lead and coordinate global and regional… 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
- 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
