- Repligen (Waltham, MA)
- …compliance teamResponsibilitiesGlobal Compliance Leadership:Develop, implement, and maintain an effective internal control framework that spans all global ... and control functions across the organization.Oversee the coordination of internal and external audits, ensuring all findings are addressed promptly and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and influence concerning Novo Nordisk global systems as well as NNI system initiatives that impact financial control and reporting of results Responsible for ... and advises various NNI stakeholders on financial, contractual, employee benefits and internal control related matters with heavy interface with senior… more
- Merck & Co. (Rahway, NJ)
- …audits and process audits, both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be ... summaries of issues and reports which accurately describe identified control concerns, associated risks, and appropriate recommendations.Participate in-department projects… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …current technology System Design and Specification Contribute to design and specify BMS systems to control HVAC and other Critical Systems Contribute to ... software Work with PM to support the commission the system , ensuring all devices and systems are...operation Programming and Configuration Assist with contractors to develop control algorithms and logic for building systems … more
- Merck & Co. (Rahway, NJ)
- …build QMS capabilities that touch every aspect of our business processes, systems , and data.The Associate Director will collaborate and interact with cross-function ... balancing effective operations with transformative initiatives.- The Associate Director, Quality System & Compliance will support to integrate the Device Supplier… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, including IQ, OQ, PQ protocols and documentation,… more
- AUROBINDO (Durham, NC)
- …internal and external regulatory inspection activities related tovalidated systems .Provide support to Quality Programs such as Data Integrity ... and data integrity governance activitiesHands-on experience managing user account setup, system configuration, and access control for QA IT systemsDemonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to ... CLM, Rep Triggered E-mails, etc. They'll also collaborate closely with internal IT stakeholders and various external vendors to deliver solutions.Responsibilities-… more
- Merck & Co. (Durham, NC)
- …process automation in a GMP environment.Experience programming Emerson DeltaV.Computer system validation and systems life-cycle development methodology ... Job DescriptionOur Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive… more
- Merck & Co. (Sacramento, CA)
- …technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of large molecule ... maintain strong relationship with External Entities, as well as internal operations, technology, analytical and procurement organizations. Closely collaborates with… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... the Head of Biologics Cell Culture Sciences and working in conjunction with internal and external partners, this individual will support late stage and commercial… more
- Eisai, Inc (Raleigh, NC)
- …for providing an uninterrupted supply of quality products to our patients, internal DCU customers, and select Partners, both domestically and globally. Planning and ... allow fully compliant transportation and storage of all materials under their control .Understand supplier and industry capabilities and trends to be familiar with… more
- Repligen (Waltham, MA)
- …hardware engineers, and product management teams to validate that our integrated systems meet user expectations and quality standards. You will also be encouraged ... for software running on hardware-based platforms.Conduct functional, regression, integration, system , and performance testing across software and hardware components.Set… more
- Merck & Co. (Rahway, NJ)
- …security certification such as Certified Professional Accountant (CPA), Certified Information Systems Auditor (CISA), Certified Internal Auditor (CIA), Certified ... across all our company's divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager ... to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data handling, techniques, standards, methodologies, and skills in working with internal and external systems , CROs, and vendors. Excellent verbal/written ... Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of… more
- Aequor (Bothell, WA)
- …AM-5:30 PM Top Skills: EDU Requirement: HS Diploma Experience with software systems like ERP/SAP/Smart Sheet Manager is looking for authenticity during interviews ... the role will be to provide material movement and logistical support to internal and external customers in support of cellular therapeutic manufacturing at the… more
