- Genmab (NJ)
- …handling to internal teams and vendors.Support cross-study harmonization of data quality practices. Process Excellence and Standards DevelopmentDrive the ... would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within Clinical Data Management. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory ... or updated procedural documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Executive Director, Head of Launch Excellence Strategy will guide launch strategy and execution at NNI - for the ... reporting requirements. The role has a team of Launch excellence leads and PMO (in-house as well as external...to address any challenges or roadblocks in the launch process . Coordinate interlinked launches across therapeutic areas or indications,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Associate Director - Launch Excellence will guide launch planning and execution at NNI - for the portfolio and ... growth and success. Relationships Reports to Executive Director Launch Excellence . Collaborates with cross-functional teams, including, brand marketing, enterprise… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and/or contingency workers. Essential Functions Deviation Management Develops and serves as Quality Point of Contact for PV Deviation process covering NNI ... program to ensure process compliance within the scope of the Center of Excellence (COE) Proactively identifies quality drift in NNI Patient Safety and NNI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry best practices.Ability to facilitate through proactive and strong leadership; business process excellence to facilitate process simplification and ... areas centered around rare diseases and immune disorders. SummaryThe Sr. Director, Data Quality and Integrity (Global R&D & PV QA) ensures high standards of data… more
- Merck & Co. (Durham, NC)
- …Inventory Management, Management Process , Manufacturing Processes, Manufacturing Quality Control, Operational Excellence , People Management, Process ... This position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …- Launch Operations will play a pivotal role in managing the launch process with the therapeutic area leads to ensure alignment with organizational objectives and ... a proven track record in program management, coupled with expertise in launch excellence methodologies and practices. This role is critical in ensuring that new… more
- Merck & Co. (Rahway, NJ)
- …members of the business in the category during the course of the Sourcing Excellence Process (SEP).Typical Activities : Meetings with stakeholders to discuss SEP ... development, etc.Data Analytics, Reporting and Actionable Insights - Work closely with the Process Excellence team to deliver meaningful data and insights- that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Eisai, Inc (Raleigh, NC)
- …(SCM) Unit is accountable and/or responsible for providing an uninterrupted supply of quality products to patients and DCU customers in their respective regions. The ... Director, Western SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance, Logistics, and Supply Chain support while interfacing… more
- Merck & Co. (Durham, NC)
- …Inventory Management, Management Process , Manufacturing Processes, Manufacturing Quality Control, Operational Excellence , Packaging Operations, People ... the unique opportunity to give input in the design process , startup their areas, and lead the teams to...that Shift(s) objectives are achieved while reliably supplying a quality product at a competitive cost consistent with our… more
- Merck & Co. (Rahway, NJ)
- …to create future robustness.Primary Responsibilities:Business Savviness and Executional Excellence :Develop and communicate a clear vision and ensure execution ... ensuring that all initiatives are executed efficiently and meet quality standards, timelines, and budgetary requirements.Drive resource allocation, prioritization of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our focus ... as a key member of the Novo Nordisk US Operations (USO) AI Center of Excellence . The individual will lead and manage a team of data scientists, including AI/ML… more
- Merck & Co. (Durham, NC)
- …Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between ... accountable for establishing a strong business partnership and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …making. The role requires strong collaboration across Site MSAT teams, Manufacturing, Quality , Process Development, and Engineering to ensure that innovative ... transfer activitiesDrive cross-functional collaboration with Site MSAT, Manufacturing Operations, Quality , Process Development, and Regulatory to facilitate… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Medical Device Testing, Multidisciplinary Collaboration, Operational Excellence , Optimistic Attitude, Preventive Action, Process Analytical ... with analytical projects leads and Device Development & Technology, Development Quality , and Strategy Leads.Support, manage, and coordinate analytical support for… more
- Merck & Co. (Rahway, NJ)
- …for a dynamic and visionary-Director, Drug Substance Leader-to drive innovation and excellence across our Biologics Science & Technology (S&T) portfolio. In this ... a culture of initiative, creativity, and problem-solving Deliver robust DS process and analytical strategies to enable successful commercialization Provide technical… more
- Twist BioScience (South San Francisco, CA)
- …closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams ... custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom… more
- Merck & Co. (Rahway, NJ)
- …Engineering Standards, Estimation and Planning, Maintenance Supervision, Management Process , Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing ... long-term robust manufacturing, enhance data monitoring capabilities, and drive excellence in safety, compliance, supply, and productivity.Global Impact:Collaborate with… more
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