- Merck & Co. (Rahway, NJ)
- …Plan for each MDCP Program (with target dates) for execution.Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation ... the device constituent part of a Combination Product.Manage activities within electronic computer systems , eg, Material Management Systems (SAP), Document … more
- Eisai, Inc (Raleigh, NC)
- …a difference. If this is your profile, we want to hear from you. The Director Western Supply Chain Management (SCM) Unit is accountable and/or responsible for ... The Director will develop colleagues with expertise in relationship/project management , contract review and negotiation, demand planning, and logistics to manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to quality standards in ongoing projects and processes.Coordinate with the Quality Management System (RDPVMA) teams to support the audit functions, including ... effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global QMS, QMS (GMP-QA).Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Merck & Co. (Rahway, NJ)
- …rigorous technical support processes to support manufacturing sites, proactive risk management , performance monitoring, and continuous improvement.-Experience ... at all levels, ensuring their commitment to the technical transfer vision. Risk Management , Compliance Oversight & Decision Making:Lead the establishment… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary:The Associate Director , Global Alzheimer's Disease Project Management is responsible for facilitating the ... Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Alzheimer's Project Management Office is from :162,600-213,400Under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a fast-paced environment, continuous improvement, project management , change management , and risk management . Responsibilities: Leadership, Direction, ... around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for...or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management . required- 4+… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems . Qualifications: EducationRequired - Technical BS degree or… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for leading a… more
- Merck & Co. (Durham, NC)
- …Assessment, Regulatory Inspections, Regulatory Requirements, Scope Change Management , Strategic Thinking, Technical Guidance, Technology Transfer-Preferred ... a successful Validation support of the vaccine manufacturing facilities.The Associate Director , Validation will be responsible for providing Validation leadership as… more
- Repligen (PA)
- …(including Workday and other tools), ensuring integration,data accuracy, and operational scalability. Risk Management & Compliance Monitor and ensure current and ... OverviewThe Director , Global Payroll will lead the development and...financial planning, workforce expansion, andglobal operational efficiency.Cross-Regional Coordination & Systems OversightPartner closely with regional payroll and HR teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Merck & Co. (Rahway, NJ)
- …Systems Auditor (CISA), Certified Internal Auditor (CIA), Certified Management Accountant (CMA), Certified Fraud Examiner (CFE).Experience with Sarbanes-Oxley ... (MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI and US Holding Companies Provides input and influence concerning Novo Nordisk global systems as well as NNI system initiatives that impact financial control ... Supply Chain. Reporting into this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls, and Director - US R&D… more
- Merck & Co. (Rahway, NJ)
- …Ethical, resilient, and committed to scientific and operational excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a matrixed global teams environmentMust have a broad understanding of quality management system , GxP regulations and industry trend/practiceMust have strong ... and trainersWorking with eCompliance as Global Business owner for ALTOS global system following governance modelLead training related risk analyses and escalate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with PBM/payer customers. Relationships Reports to the Executive Director , Strategic Pricing & Contracting. Responsible for leading a team of ... to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts o… more
- Merck & Co. (Rahway, NJ)
- …Environmental Regulatory Compliance, General Safety, Health Safety, Health Safety Management System , Incident Investigations, Industrial Hygiene, Industrial ... Management , Occupational Hygiene, Oral Communications, Project Management , Project Management Improvement, Project Planning, Project Risk Assessments {+ 5… more
- Repligen (Waltham, MA)
- …activities are documented, tracked, and aligned with the company's overall risk management strategy.Evaluate and implement new tools, technologies, and ... risks, developing strategies, and implementing effective controls.Experience with ERP systems , financial reporting software, and compliance management tools… more
- Merck & Co. (Rahway, NJ)
- …and inspire accountabilityEthical, resilient, and committed to excellenceSkilled in risk management , team facilitation, and strategic planningExperience in ... Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance, Results-Oriented, Technology Transfer-Preferred Skills:Job Posting End… more
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