- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, ... areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology, ... metrics, analysis, and reporting. Establishes an operational approach along with systems and documented procedures and processes to ensure appropriate operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... for improving Talent Acquisition processes so they are aligned with legal and regulatory guidelines. Ensure that the integrity of US regulations and laws are upheld… more
- Repligen (Waltham, MA)
- …Proficiency in conducting risk assessments and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, ... supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Aequor (Thousand Oaks, CA)
- …role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. Let's ... supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions to mitigate against… more
- Merck & Co. (Durham, NC)
- …guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits ... and route engineering change requests through CMMS system.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvementThe… more
- Twist BioScience (South San Francisco, CA)
- …processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you will report ... to the QC manager .What You'll Be Doing Review and release products based...analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll Bring to the… more
- Novo Nordisk Inc. (Durham, NC)
- …Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet all customer, business & ... regulatory requirements through the following activities: People Focus, Process...Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to Manager , Technical Support. Essential Functions Coach & mentor peers,… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp… more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture,… more
- BD (Becton, Dickinson and Company) (Cayey, PR)
- …for improvement, evaluating corrective actions, and determining its effectiveness. The Quality Systems Manager will facilitate regulatory inspections and ... Description Summary** This position reports to the Sr. Quality Manager . The Quality Systems Manager ...regulatory requirements and company policies. + The Quality Systems Manager will perform as Lead Auditor… more
- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager **Department:** Quality Assurance / Regulatory Affairs **Classification:** Exempt **Reports To:** ... company leadership and direction for worldwide Tecomet's Quality Assurance and Regulatory Affairs Systems , encompassing both improvements and sustaining… more
- Safran (Grand Prairie, TX)
- Quality Regulatory Manager Company : Safran Helicopter Engines Job field : Quality Location : Grand Prairie , Texas , United States Contract type : Permanent ... Grand Prairie, Texas is hiring a Quality, Safety, and Regulatory Manager to play a critical role...* This position requires an understanding of Quality Management Systems , regulatory requirements, meticulous attention to detail,… more
- RWJBarnabas Health (Somerset, NJ)
- Regulatory Planning Manager (Hybrid) - Somerset, NJReq #:0000170498 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas Health ... the Department through establishing, tracking project milestones and coordinating submissions. Manager assists in obtaining regulatory approval for enterprise… more
