- Merck & Co. (Rahway, NJ)
- …and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards. Lead risk ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial...and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and… more
- Bayer (Whippany, NJ)
- …development and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. ... difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports… more
- Insmed Incorporated (NJ)
- …for assigned products. Lead the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory ... and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports… more
- Cipla (Fall River, MA)
- …regulatory submission while closely working with regulatory teams. Prepare and review risk assessment (FMECA) for various facility, equipment, process and ... the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at...particular event etc. Prepare and review elemental impurities risk assessment and nitrosamine related risk… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Merck & Co. (North Wales, PA)
- …supply of direct and indirect materials, performing the supplier relationship management, supply risk assessment with actions in place and regular tracking, and ... Job DescriptionThe Global Packaging Procurement Director is responsible to lead the Packaging Center of Excellence (COE) organization. The...scope of services under the supplier are executed in compliance with the contract and in a timely manner.… more
- Insmed Incorporated (NJ)
- …, and environmental protection for all Insmed locations.Key duties include risk assessment , developing safety policies, managing training programs, and ... ensuring compliance with regulations like OSHA, EPA, and other federal,...of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide… more
- Merck & Co. (Rahway, NJ)
- …related activities to go live with new equipment and infrastructure (eg Quality risk assessment , safety assessment , data integrity, change management, ... (CSO), Logistics and Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP ... necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The… more
- Merck & Co. (Rahway, NJ)
- …Efficiencies, Production Process Development, Production Scheduling, Raw Material Sampling, Risk Control Assessment , Safety Protocols {+ 5 more}Preferred ... innovation.- They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and… more
- Merck & Co. (Durham, NC)
- …and Instrumentation DiagramsLean Six Sigma belt certificationExperience with process risk assessment toolsExperience with responding to regulatory questions ... Process Optimization, Process Technologies, Procurement, Professional Integrity, Project Management, Risk Control Assessment , Root Cause Analysis (RCA),… more
- Syner-G BioPharma Group (Boston, MA)
- …support for improvement projects regarding processes and systems.Support or provide risk assessment and mitigation activities for process development, ... development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit. Lead start-up… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics and Distribution… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes ... pre-deal assessment /analysis, development of business cases for Pricing Committee, offer...as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy, Legal,… more
- Formation Bio (New York, NY)
- …storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role ... to integrate artificial intelligence (AI) technologies to improve efficiency, compliance , and overall quality assurance practices.Responsibilities Ensure compliance… more
- Merck & Co. (Millsboro, DE)
- …in relation to establishing supply strategy and proactive mitigation of supply risk /issues. Lead Stakeholder engagement meetings, schedule routine reviews and be ... using electronic procurement platform: ARIBA. Ensuring all Business Requirements are captured, lead the assessment of the proposals using predefined criteria… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Quality, Safety, Compliance , IT based on business understanding and risk assessment ; collaborate with requesting business stakeholders as needed Triage ... in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply with ... The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP guidelines and local regulations, ensuring inspection readiness… more
