- Merck & Co. (Rahway, NJ)
- …Understand the big picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or ... products Experience in design controls, ISO 13485, deviation management, change control , risk management/ISO 14971-2019 and the fundamentals of documentation… more
- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... strategic and tactical technical direction through cross-functional partnerships with key business units and customers. Your leadership will be instrumental in… more
- Merck & Co. (Rahway, NJ)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... External Manufacturing Operations is accountable for establishing a strong business partnership and ensuring excellence in Compliance, Supply, Continuous… more
- Merck & Co. (Rahway, NJ)
- …execution, analysis, and documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and ... global health authorities (FDA, EMA, JNDA, TGA) Unite diverse internal and external teams to deliver as One Team...team achievements and promote a culture of appreciation Lead business improvement initiatives and leverage networks to drive change… more
- Merck & Co. (Rahway, NJ)
- …as needed - Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence ... clinical development teams and the operational/executional arms within the business . Working independently, the Protocol Clinical Supplies Project Manager (Protocol… more
- Merck & Co. (Rahway, NJ)
- …This program provides guidance in customs valuation methodologies and determines control processes for no-sale/free of charge shipments. CIT is also responsible ... related legislative changes globally. Coordinate communication of changes to the business in collaboration with ECO Global Trade Standards & Controls… more
- Merck & Co. (Rahway, NJ)
- …technical documentation in support of the following: process characterization (PC), risk assessment (RA), control strategy, comparability reports, and/or ... development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation,… more
- Merck & Co. (Rahway, NJ)
- …as needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence ... between clinical development teams and the operational/executional arms within the business . The Program Clinical Supplies Project Manager (Program CSPM) serves as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Scientists and Engineers support internal development and internal /external manufacturing operations to remain operational, continuously ... development including cell banks, process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation,… more
- Merck & Co. (Rahway, NJ)
- …( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, partnering with ... eg XEVMPD, IDMP, PQCMC, SPL etc . )- - Internal & External Stakeholder Engagement and Change Management for...quality measures specified in local SOPs- - Data Centric Business System Owner Operations: Lead the regulatory data governance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leads and provides actionable recommendations based on a) thorough analysis of internal and external business issues and environmental factors b) careful ... Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the… more
- Merck & Co. (Rahway, NJ)
- …participation.Represent BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent ... under tight timelines in a rapidly changing environment.Experience leading internal and external cross-functional, matrixed teams.Demonstrated scientific leadership with… more
- Merck & Co. (Rahway, NJ)
- …and other activities.- In performing these activities, they will interface with internal clients, external vendors and service providers as well as government ... and equipment, with accurate Harmonized Tariff classifications (HTS), Export Control Numbers (ECN), Controlled Substance Schedules, and other government agency… more
- Merck & Co. (Rahway, NJ)
- …(SORs) to promote fast and efficient closure. - As needed, safely perform High Risk Work involving hazardous energy control . - Identify and follow through on ... (SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and advises various NNI stakeholders on financial, contractual, employee benefits and internal control related matters with heavy interface with senior ... Responsible for establishing a strong and sustainable environment of internal control compliant with Sarbanes Oxley Sec...Sec 404 requirements Manage/reduce the Company's exposure to fraud risk and routinely evaluate business processes and… more
- Mizuho Corporate Bank (New York, NY)
- Business Risk and Control - Internal Control Testing (ICT) AVP: Business Risk and Control (BRC) is a 1st line of defense Operational ... and legal entities across Mizuho US Operations (MUSO). The Business Risk and Control team...based Internal Controls Testing (ICT) Program. As Business Risk and Control ICT… more
- Warner Bros. Discovery (New York, NY)
- … strategies and objectives. This includes actively supporting the business with risk , process and internal control perspectives in ongoing transformation ... synergies. In this pivotal role, you will serve as a business process, risk , internal control , and Internal Audit (IA) subject matter expert across… more
- Deloitte (Morristown, NJ)
- …or FFIEC 101 + Understanding of business processes, regulatory requirements, risk management, internal control management, process, data and technology ... governance processes + Developing and implementing regulatory reporting policies, including risk and control assessments, operational and data controls, and… more
- American Express (New York, NY)
- …and systems (along with business process owners) + Facilitate BUs in their risk assessments performance (eg, Risk Control Self Assessment (RCSA) ;Process ... processes (eg, cross-BU process- control mapping) + Support risk management practices within the business +...experience in operational risk management (eg, within Risk and/or Internal Audit function) Understanding of… more
- Travelers Insurance Company (Morristown, NJ)
- …or customer. + Serve as a mentor and technical resource to Risk Control field organizations and internal business partners. + Collaborate in technical ... relevant communications with Technical Unit Manager, Regional Managers and Risk Control staff. + Develop technical content for internal and external use… more
