- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across ... as needed Own and manage testing of local owned systems - SAP and Web Benefit audits Coordinates annual...what it takes mindset and positive attitude Commitment to Quality - dedicated to providing the highest quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that all stakeholders are aligned and informed. Ultimately, the Content Project Manager plays a critical role in delivering high- quality digital content ... similar project management tools Strong hands-on knowledge of Content Management Systems related platforms (specifically, Adobe Experience Manager , Adobe Assets,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …priority Drive innovation through enhancements in the organization, processes, and use of systems and data and implement data quality initiatives Responsible for ... ready to maximize your potential with us? The PositionThe Manager of Master Data will work within the Master...Team and will have responsibility for Master Data implementation, quality initiatives, and reporting as well as ensuring Master… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …routine tasks) by identifying processes for automation Identify data source gaps and quality issues and liaise with stakeholders to solve issues swiftly Strong drive ... of 8 years of experience in the following areas; Supply chain, BI systems , analytics, digital, finance, commercial, data architecture, digital systems and… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …at the sitePerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete tasks, ... Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality ...is a plus.Ability to identify/remediate gaps in processes or systems .Experience reviewing/auditing GMP documentation including but not limited to:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to the facility, equipment lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such ... global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.- Communication and ... strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors colleagues on the outsourcing process and procedures. (not… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance ... disposition to update impacted inventory in IRT and other related systems .Coordinates authorized destruction of investigational products with approved vendors and… more
- Merck & Co. (Rahway, NJ)
- …and information to meet internal and external requirements, maintain regulatory systems and technologies to support the operational needs of the regulatory ... evaluate existing workflows, and implement best practices to improve the quality , accuracy, and speed of regulatory operations activities. Perform regulatory tasks… more
- Merck & Co. (Rahway, NJ)
- …ensure high quality data and timely and complete synchronization between systems . Acts to resolve all issues and discrepancies as data stewards responsible for ... include, but are not limited to, the following: Strong knowledge of Systems Applications and Products in Data Processing, Business Planning and Consolidation, SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …up to date solutions. Oversee the testing strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with ... quality assurance teams to ensure that all non-regulated systems are thoroughly tested before deployment. Manage API based integrations of various systems ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …They will use knowledge of architecture and development patterns for on premise systems and public cloud to design and deliver solutions to meet requirements. The ... and maintaining interfaces between enterprise applications, infrastructure, and security systems such as ServiceNow, Qlik, PowerBI, AWS, Azure, Anomali, Splunk,… more
