- 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)
- …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)
- …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)
- …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)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… 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)
- …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)
- … risk posture. Define the requirements, best practices, and lead the collaborative development of cloud system/service architecture, design, and engineering. ... development, engineering, and deployment of security controls used to protect. Ensure compliance with all requirements applied to cloud services and technology. -… 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
- 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
- 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
- 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
- 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
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal advisor ... Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and...and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business partnership with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor processes and systems for continue to enhance programs. - Legal and Compliance Management - Manage and oversee complex processes for approval of material ... and compliant execution of all congresses.Responsibilities- Congress Planning and Execution Management - Manage the planning and onsite execution for the global and… more
