- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing ... resource planning for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team… more
- Merck & Co. (Durham, NC)
- …be required to be fully vaccinated as a condition of employment.The Lead Maintenance Technician is a leader with strong interpersonal, communication, and ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Merck & Co. (Durham, NC)
- …improve quality without compromising superior customer service . FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement ... be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives.-Individual contributor role working with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices. The position also involves risk-based validation of IT services and determining audit targets for GxP systems.ResponsibilitiesLeadership and Strategic ... Global QMS (RD PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art data-driven solutions.Design a… more
- Merck & Co. (Rahway, NJ)
- …evidence packages to be submitted to regulatory agenciesSupport the PaCES lead to coordinate the development, validation, implementation , and utilization of ... PaCES lead to collaborate with individuals from Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint… more
- Merck & Co. (Rahway, NJ)
- …many diverse areas including Biological, Chemical, Automation, Safety, Technical Services , Process Development, Analytical, Regulatory , and Quality.As part ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... position requires demonstrated line management experience and the ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- …- We are looking for an experienced Associate Director of SAP Security to lead our SAP security initiatives and drive strategic security programs. This role will ... shaping the security posture of our organization and ensuring compliance with regulatory requirements This Associate Director role will be responsible for: Strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …risk areas ensuring comprehensive monitoring across all NNI departments, functions, services , and vendors. This position is accountable for delivering critical ... of compliance professionals to ensure robust monitoring of NNI departments, functions, services , and vendors in line with Ethics & Compliance program needs Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned with the Global ... QA and Development QA to provide QA advise wherever necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical… more
- Aequor (Thousand Oaks, CA)
- …and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, interpreting, ... to change requests approved by management. 4. Work within the Information Services and Quality Systems teams to foster good communication throughout the project… more
- Merck & Co. (Rahway, NJ)
- …engineering, and data science expertise. We enable data, technology and services that accelerate our scientists' ability to discover and develop innovative ... team, the Product organization is responsible for implementing capabilities and associated services to advance the drug discovery and development pipeline. Our IT… more
- Eisai, Inc (Exton, PA)
- …management processes and procedures for GxP systems as assigned.IT System Implementation and Maintenance: Responsible as assigned for validation strategies and ... solutions, hosted systems and external suppliers and partners.Engagement with Regulatory Agencies: Collaborates with management to engage with regulatory… more
- Eisai, Inc (Exton, PA)
- …groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics ... review for phase III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position Responsible for the design and implementation of manufacturing processes, instrumentation and equipment start-ups from bench top ... commensurate with candidate experience and qualifications. Relationships Reporting to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to implement new innovative manufacturing technologies.Key Responsibilities Individual will lead a team to support manufacturing investigations, capacity planning, ... with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as Subject… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …realize your potential? The Position Responsible for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from the ... this role will be commensurate with experience. Relationships Reports to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and… more
- Repligen (Waltham, MA)
- OverviewThe Director, Global Payroll will lead the development and execution of Repligen's global payroll strategy tosupport a growing global workforce. This role ... and strategic alignment globally.ResponsibilitiesResponsibilitiesGlobal Payroll Strategy & LeadershipDefine and lead the execution of Repligen's global payroll strategy. Design… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …re-balance inventories supporting manufacturing activities to provide an optimal service level and performance.Key Responsibilities Interpret and analyze demand and ... coverage and supply readiness.Monitor supplier execution and deliverables of goods and services aligned with scope of work.Monitor product life cycles and alert… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Regulated Implementation Services Lead plays a key role in overseeing ... the development, validation, implementation , and integration of GxP-regulated systems across the organization....planning for GDX global and regional projects requiring Validation services and Technical Lead assignments. **Responsibilities** +… more
