- 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 advises various NNI stakeholders on financial, contractual, employee benefits and internal control related matters with heavy interface with senior ... corporate policy Responsible for establishing a strong and sustainable environment of internal control compliant with Sarbanes Oxley Sec 404 requirements… more
- Twist BioScience (South San Francisco, CA)
- …standards, development, rigorous testing, validation, deployment, and post-go-live support for new and existing biomanufacturing facilities.System Optimization & ... Support : Drive continuous improvement and feature enhancement of existing...FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... the Director in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and… more
- Eisai, Inc (Exton, PA)
- …Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions to support successful product ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... of the Head of Biologics Cell Culture Sciences and working in conjunction with internal and external partners, this individual will support late stage and… more
- Merck & Co. (Sacramento, CA)
- …to:Analytical technical oversight working directly with the external provider(s) and internal cross-functional stakeholders to support analytical testing of ... through commercialization and launch as well as product lifecycle management support for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (ie… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the ... organization. Internal relationships include close interactions with marketing, sales, extended...other ad hoc analyses to: proactively address issues in support of company objectives, operating model decision, mitigate decision… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System Design and Specification Contribute to design and specify BMS systems to control HVAC and other Critical Systems Contribute to select appropriate control ... equipment based on the building's requirements Installation and Commissioning Work with PM to support the installation of BMS hardware and software Work with PM to … more
- AUROBINDO (Durham, NC)
- …incident management, andOversight is aligned with corporate and data protection standards. Support internal and external regulatory inspection activities related ... history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization have given Aurolife a jump start… more
- Merck & Co. (Rahway, NJ)
- …coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The ... timelines, and the study protocol/related documentation.Provide overall leadership and support to the study team. Identify and select Investigators, laboratories… more
- Aequor (Bothell, WA)
- …The primary focus of the role will be to provide material movement and logistical support to internal and external customers in support of cellular ... this role are helping to establish the JuMP warehouse operations and completing internal customer support assignments with high-quality and timely output. 0-2… more
- Merck & Co. (Durham, NC)
- …Author and approve validation procedures in accordance with our Company guidelines Support both internal and regulatory audits with coaching Subject Matter ... areas of the organization, as well as all areas of their primary support facility (ie Sterile Supply, Lyophilization, and Filling) and cross-functional teams (ie… more
- Aequor (Framingham, MA)
- …new cutting-edge technologies, for DSP sciences for life cycle management projects. Support technology transfer including projects for internal and external ... and scientists to achieve robust and scalable purification processes to support 2nd generation processes, late-stage programs, and life-cycle management. This… more
- Merck & Co. (Rahway, NJ)
- …guiding product and process development.Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices ... and/or department via presentations to governance committees and other internal audiences.Partnering with director-level management to develop and execute scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies ... between the Engineering group and the operating departments to address internal stakeholder needs ensuring that all asset qualification activities are properly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to business processes. Conduct user acceptance testing and provide training and support to end users. Participate with internal IT data teams/vendors to ... disorders. SummaryThis position is responsible for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of ... reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for… more
- Novo Nordisk Inc. (Wichita Falls, TX)
- …access to build and maintain business-relevant relationships with customers: prescribers, support staff, pharmacies, and clinic administrators to gain access and ... NNI-approved solutions Demonstrates professionalism and a customer-focused approach with internal and external stakeholders by actively listening, identifying and… 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 ... work.Under the direction of the AIC, partner with colleagues and clients, support groups, and other organizations to effectively complete all assigned audit… more
