- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team ... based in Raritan, NJ. Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of… more
- Merck & Co. (Rahway, NJ)
- …in outcomes that demonstrate the Company's commitment to regulatory compliance .Accountable for development and implementation of a proactive inspection communication ... Inspection & Enterprise Management, related to regulatory agency inspections.Act as the Quality Management subject matter expert and primary point of contact for all… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIndividual contributor responsible for ensuring the compliance of External Quality Assurance (EQA) processes against approved quality manual ... part of the EQA QRM CoE within the EQA Compliance /System team, which will provide Quality oversight...quality systems introductions and/or improvements. Assists with and/or lead the development, and ongoing execution of the … more
- Merck & Co. (Rahway, NJ)
- …state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP Technology.-They ... Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior Technology… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership ... of team members, fostering a collaborative and innovative team environment.Regulatory Compliance and Quality Assurance:Ensure that all activities are conducted… more
- Merck & Co. (Rahway, NJ)
- …you will play a crucial role in managing regulatory submissions, maintaining compliance with industry standards, and championing process improvements to enhance the ... quality and speed of our regulatory operations activities. In...as necessary. They implement and maintain processes to ensure compliance with electronic submission formats and global regulatory standards.Identifies… more
- Merck & Co. (Rahway, NJ)
- … regulations.Desire and willingness to learn, contribute and lead through independent problem-solving.Effective interpersonal and communication skills, both ... in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable… more
- Merck & Co. (Rahway, NJ)
- …the Company's pipeline. This role may support facility operations, support compliance investigations/change management, author GMP documentation and manage/ lead ... and innovation. They will work closely with the development engineers & chemists, compliance representatives, safety partners and other team members to ensure the … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as we embark on shaping our future. The Position The Rare Disease 5D Lead will be responsible for developing and implementing a Data, Diagnostics, Drug, Device, and ... ensure that stakeholders on both are in alignment related to strategy, execution, compliance , privacy and legal matters. This requirement is a must-have, and the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of materials prior to dissemination.Assists OEDC leadership with timely submission and compliance of all required DS documentation for quality control/assurance, ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...compliance and alignment with DS highest standards. Uses quality improvement techniques to increase the quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on shaping our future. The Position The Strategic Partnerships & Engagement Lead is responsible for leading the National Rare Disease field organization focused ... and Marketing Head, Hemaglobinopathies Head, Rare Disease Field Sales Lead , Business & Commercial Excellence Lead as...In addition, this role will closely partner with Legal, Compliance and Privacy. This role will serve as a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and precision ... to finding patients. Relationships Reports to Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including therapy area marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … quality standards Familiarity with healthcare regulatory requirements and compliance standards related to digital health Excellent communication and presentation ... experiment with us? The Position The Digital Health and Connected Care Lead will be responsible for envisioning, developing and implementing a comprehensive Digital… more
- Merck & Co. (Rahway, NJ)
- …The engineer will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), ... leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe,… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... well as advancing a culture of scientific excellence and compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The Experience Architect Team Lead is responsible for developing and executing MarTech strategies that enhance customer ... (CX) campaigns, ensuring seamless integration with other systems. The lead analyzes customer journeys to identify optimization opportunities, leverages data-driven… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improvement projects for the Gown Training Program. This position is responsible for quality and maintaining the highest standards in compliance within company ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Lead Operations Gowning Trainer as part of the Technical Operations team based in… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... work experience:Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensure quality control of marketing content in alignment with compliance prior to dissemination of promotional programs and other materials, including ... us? The Position The Brand (Sema AD) HCP Experience Lead will play a critical role in ensuring helping...with support of omnichannel team and squad. Ensuring compliance with industry regulations and guidelines Content Deployment:… more
