- Merck & Co. (Rahway, NJ)
- … of GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses all Human & ... and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company's policies and… more
- Merck & Co. (Rahway, NJ)
- …and tackle challenges, balancing effective operations with transformative initiatives.- The Associate Director , Quality System & Compliance will support to ... Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director...capabilities that touch every aspect of our business processes, systems , and data.The Associate Director will collaborate… more
- Merck & Co. (Rahway, NJ)
- …assessing, and mitigating potential risks to ensure patient safety and product quality .Ensure compliance with all regulatory requirements and quality ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems , and industry best practices.Exceptional… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance . Exceptional project ... focus on autoinjectors, prefilled syringes, and other drug delivery systems . The Associate Director will collaborate with...launch in alignment with the company's business goals, and quality and regulatory compliance . Essential Duties and… more
- Merck & Co. (Rahway, NJ)
- …results, remove barriers on portfolio or scientific prioritiesEvaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Rahway, NJ)
- …Cell Culture, Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting End ... with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics… more
- Merck & Co. (Rahway, NJ)
- …Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for leading a ... Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization… more
- Merck & Co. (Rahway, NJ)
- …cross-functional teams.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends ... accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a culture of diversity, inclusion, and… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance , Results-Oriented, Technology Transfer-Preferred ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Merck & Co. (Rahway, NJ)
- … Director , Clinical Trial Central Labs to support high quality sourcing initiatives and procurement category management. Primary Activities: Contract Execution ... collaboration with the CDSP team; ensure contracts are filed to the appropriate systems and tracked internallySourcing - to assist in creating and executing RFIs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … quality standards are met.Proactively assess and address operational gaps related to quality systems and compliance , fostering a culture of sustainable ... R&D & PV QA) ensures high standards of data quality and compliance within Global R&D &...for GxP systems .ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity is essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Global Director of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is ... seeking a Global Director of Platform Innovation within our Global MSAT organization...role requires strong collaboration across Site MSAT teams, Manufacturing, Quality , Process Development, and Engineering to ensure that innovative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and support materials for end-users, handling of queries, troubleshooting, and quality control.Lead or support consulting and implementation projects in the area ... formats, correct inaccuracies, and validate the cleansed data against defined quality metrics.Implement and manage robust data governance processes to ensure ongoing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure a consistent brand/therapy area vision and message. Relationships Reports to Director of Brand. Responsible for providing interface with key internal and ... measurement of KPIs to assess the success of HCP engagement strategies Health Systems Strategy o Collaborate with medical affairs and market access teams to inform… more
- Merck (Rahway, NJ)
- …and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director , Quality System & Compliance will support to ... Functions & Responsibility** As a member of the Device Quality & Regulatory QMS group, the Associate Director...capabilities that touch every aspect of our business processes, systems , and data. The Associate Director will… more
- Merck (Rahway, NJ)
- … of GMP Compliance will report to the head of the Global Quality Compliance Support organization. The responsibility of this position crosses all Human & ... and research services to global QMS topic owners and site quality experts to assess the compliance impact of potential updates to our company's policies and… more
