- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire ... Lead the global teams in the execution of Risk and Compliance initiatives and support professional... and Compliance initiatives and support professional growth. Risk Management : Develop and manage global … more
- Eisai, Inc (Nutley, NJ)
- …occurrences. This role will be required to provide input into vulnerability management , risk management , security architect, security operations center ... Demonstrated expertise in incident response, threat intelligence, security controls, and risk management .- Solid understanding of protocols (ie., SAML, SMB,… more
- Merck & Co. (Rahway, NJ)
- …and leadership skills.Project management experience including resource management , budget forecasting, and risk assessment/mitigation planning.Comfort with ... Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical Research… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification and validation, design controls and device risk management techniques to positively support and influence ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Merck & Co. (Rahway, NJ)
- …Units (OpUs) as it relates to in-line product management , supplier management , risk management and savings identification.Works closely with DMLT ... while remaining a financial steward.Scope:-Responsible for all in-line product execution, risk management and escalation.-Emphasis on matrix management … more
- Merck & Co. (Rahway, NJ)
- …Quality oversight of Quality and Business processes with EQA related to Quality Risk Management .- The incumbent will also drive and/or participate in cross ... domestic and foreign regulations and compendia governing plant operations. Strong project management skills Trained Quality Risk Management (QRM) Facilitator… more
- Merck & Co. (Rahway, NJ)
- …Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... (SPD) team. The successful candidate will be expected to lead the team focused on the design of new...as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- … based and lean approach to compliance activities.-This role reports into Compliance Lead for above site systems.Responsibilities but not limited to: Support ... requiredResponsible for Identifying and engaging in remediation of above site IT/OT compliance risksExecute risk assessments to evaluate the implementation of… more
- Merck & Co. (Rahway, NJ)
- …or manager.-Requires strong understanding of local regulatory environment-Ability to proactively develop risk management and mitigation plans in the country and ... Job DescriptionThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation...Audit and Compliance QA function to develop compliance and risk criteria, in order to… more
- Merck & Co. (Rahway, NJ)
- …regulatory requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and ... 4). Lead quality oversight of product validation, verification, and risk mitigation activities.Regulatory CMC OversightLead the preparation and submission of… more
- Merck & Co. (Rahway, NJ)
- …commercialization.Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control ... methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance .Talent retention, training/upskilling, and… more
- Merck & Co. (Rahway, NJ)
- …Director is responsible for forecasting, budgeting, S&OP, life cycle management , financial evaluation, and business development activity for their business ... closely with cross functional teams, including commercial, research, manufacturing, legal, compliance and corporate teams to identify, evaluate and execute strategic… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics… more
- Merck & Co. (Rahway, NJ)
- …and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies and practices Intellectual property (IP) Technology ... Technology & Operations to provide application administration and technology management support to the Intellectual Property (IP) organization.Primary responsibilities… more
- Merck & Co. (Rahway, NJ)
- …communication and collaboration skills.Good organizational, interpersonal, writing, and time management skills. Lead and operate within a cross-functional process ... leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe,… more
- Merck & Co. (Rahway, NJ)
- …- gives us a wide-angle perspective that we use to optimize opportunities, mitigate risk and achieve the company's goals. We align as a cohesive team with shared ... creative motivated individual who will provide thought leadership and lead best-in-class social media content development, publishing, monitoring and engaging… more
