- Eisai, Inc (Nutley, NJ)
- …the Executive Director, IT Security, Compliance , & Architecture, s/he is the Global IT department's trusted leader and manager who assesses and provides ... a difference. If this is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing… more
- Merck & Co. (Rahway, NJ)
- …any case very competitive.Animal Health Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving ... Job DescriptionWe are looking for an engaged and energetic, people-oriented leader with advanced technical skills to lead , develop, and mentor an international… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... Global DX Computer System Validation policies and procedures in collaboration with global DX and global Quality departments. Evaluates key performance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Operations and Sourcing (GOS) lead is responsible for owning supplier relationships, executing sourcing strategy, developing, and ... partners to ensure requirements are understood and effectively managed. The leader must have excellent communication and relationship skills.Key Roles &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes ... issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Merck & Co. (North Wales, PA)
- …review of the CMC Regulatory Strategy Document for projects of increasing complexity. Lead development and execution of detailed, global regulatory submissions of ... sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and… more
- Merck & Co. (Rahway, NJ)
- …a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements.-Key ... the local policies of work commuting.Essential responsibilitiesManages a team of Quality Assurance professions as direct reports and complies with company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key global DS oncology early development initiatives. The Program Lead will have direct accountability for administrative deliverables, will interact regularly ... of materials prior to dissemination.Assists OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance,… more
- Merck & Co. (Durham, NC)
- …Sponsor for Safety Committee goals, both at the department and site level. Quality Compliance :Responsible for self-identifying and addressing gaps from internal ... Job DescriptionWe are recruiting a Lead position within the Supply Chain Management team...This leadership role is the key interface between Durham, global Supply Chain organizations and our internal and external… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe LATAM regional lead for Technology Procurement manages commodity and vendor ownership -within IT professional Services, Software, Hardware, and ... Telecom categories. The role reports to the Director of Global Technology Procurement Hardware, Infrastructure, Telecom. This position will take an active role in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive ... our future. The Position The Strategic Partnerships & Engagement Lead is responsible for leading the National Rare Disease...In addition, this role will closely partner with Legal, Compliance and Privacy. This role will serve as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … quality indicating data and identifying trendsProvide oversight for trending of quality compliance metricsWork in a collaborative team setting with ... the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality oversight over the production… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures as needed.Ability to manage multiple ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The HCP - Strategy Lead (MASH) lead will be a pivotal driver in shaping an insights-driven HCP ... area vision and message. Relationships Reports to the Integrated TA Strategy Lead . Responsible for providing interface with key internal and external stakeholders.… more
- Merck & Co. (Rahway, NJ)
- …Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate… more
- Merck & Co. (Rahway, NJ)
- …innovations and improve patient health outcomes. Under the guidance of a senior leader , this individual will support one or more V&I, Outcomes Research teams across ... plans. Provide outcomes research leadership on cross-functional regional and global teams.Critically assess drivers and barriers to reimbursement and market… more
- Merck & Co. (Rahway, NJ)
- …GMP investigations and deviation (OOS & OOT) management.Strong knowledge of current global regulatory standards and best practices related to all aspects of CCIT ... written and oral communication skills.Ability to collaboratively work and lead in a multi-functional & -disciplinary working environment.Preferred Experience and… more
- Merck & Co. (Rahway, NJ)
- …improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations and quality standards, including ... design and development processes (Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product validation, verification, and risk mitigation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Support and lead continuous improvement projects.Managing people to support Quality improvement initiatives.Provide quality and compliance input for ... and commercial requirements in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous improvement efforts, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …efforts, site escalations, and quality projects.Key Responsibilities Provide quality and compliance input for identified continuous improvement efforts ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...associated with the manufacturing site. Lead assigned Quality tasks associated with process… more
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