- 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
- 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)
- …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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports and/or leading multidisciplinary teams, as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of ... experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data… 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
- 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
- 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
- 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
- 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
- Aldevron (Miami, FL)
- …dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for ... human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and...be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the… more
- Pall (Putnam, CT)
- …everything possible.Director Global Supplier QualityJob Description SummaryProvide quality assurance services to ensure the integrity of products received and ... shipped out, services provided to clients, support business and customer needs,...to support market release of new product development. May lead audit and inspection preparation, resolution of audit and… 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
- Community Health Systems (Valparaiso, IN)
- …performance improvement activities for audit readiness. + Regularly update hospital staff on regulatory changes and lead implementation of new quality ... performance improvement methodologies, and evolving regulatory standards. + Develop and lead in- service education sessions covering JC, OSHA, CDC, and other … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Lead Enterprise Architect (Product Development & Regulatory Compliance) ... and IT needs are fulfilled. To achieve this the Lead EA collaborates across EA domains and Global IT...a medical condition, genetic information, ancestry, veteran status or service in the uniformed services , and any… more
- Mizuho Corporate Bank (New York, NY)
- …processes for explaining changes in the FR2052a reporting data. Responsibilities + Lead and manage the Liquidity Regulatory Reporting Mizuho Americas LLC ... to regulatory requirements. Identify opportunities for process improvements and lead FR2052a reporting initiatives linked to the ongoing migration to Axiom and… more
