- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA program ... Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the… more
- Merck & Co. (Rahway, NJ)
- …Control Systems , Electronic Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance Team Building, ... Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research… more
- Insmed Incorporated (San Diego, CA)
- …they are accurately represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordination with appropriate teams Support facility certification for new Manufacturing ( process equipment & facility-support equipment) and Quality Control ... are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product...role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready? The Position Responsible for leading process , reporting and compliance related activities for US Talent Acquisition. Responsible ... Relationships Reports to the Head of US Talent Acquisition. Partners closely with Global , Regional and Local Leaders. Interacts with other HR colleagues, global … more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation through active… more
- Novo Nordisk Inc. (Durham, NC)
- …Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will improve/develop systems & equipment for the ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...improvements. Develop plans to improve the performance of a process or set of systems , using green… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything… more
- Repligen (Boston, MA)
- …and driven Bioprocessing Sales Specialist to join our team, focusing on Process Analytics Products for downstream Process Analytical Technology (PAT) using ... cutting-edge technology to enhance bioprocessing workflows.Repligen Corporation is a global leader in bioprocessing technology and innovation, committed to… more
- Merck & Co. (Rahway, NJ)
- … Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System, Quality Management, Quality Management ... products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities ... actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may… more
- Merck & Co. (Rahway, NJ)
- …as Global Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for...incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical… more
- Aequor (Thousand Oaks, CA)
- …using appropriate key performance indicators. Provides guidance and technical advice on global supply chain processes and systems . Responsible for full Value ... will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. Let's change the… more
- Merck & Co. (North Wales, PA)
- …in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ability to turn strategy ... of medical drugs and vaccines for the benefit of patients and global human health.This position supports statistical programming activities for multiple and/or late… more
- Aequor (Athens, GA)
- …and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air. ... Conduct regular inspections and preventative maintenance to ensure systems are operating efficiently and safely. Engage in technical activities/troubleshooting… more
- Merck & Co. (Rahway, NJ)
- …testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems .Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global ...and advocate for scalable, compliant architecture and design.Collaborate with global quality , IT, and business leaders to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Product & Process Development (DPPD) Team within our Device Development & Technology (DD&T) organization designs, develops, and ... for applying deep subject-matter expertise and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
