- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oversight Plan etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with ... end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the...accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies… more
- Cipla (Fall River, MA)
- …company remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk assessments and help mitigate any potential quality risks to product ... an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external … more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... teams and stakeholders to ensure that all platforms meet safety, efficacy, quality , and robust supply standards. Develop and maintain strong relationships with… more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... Lead efforts to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request for Quotation) Process… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Durham, NC)
- …Professional Integrity, Project Management , Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Operations, Risk Assessments {+ 5 ... as formulation, filling, lyophilization, or automated inspection processesFamiliarity with process risk assessment tools, Quality by Design principles, and… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- ValSource, Inc. (Rahway, NJ)
- …for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is required. Willing and able to travel as necessary ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Cipla (Fall River, MA)
- …management committee, commercial, portfolio, R&D technical staff, supply chain management , medical affairs, regulatory affairs, quality assurance, procurement ... Cipla is a leading global pharmaceutical company, dedicated to high- quality , branded, and generic medicines. We are trusted by...contributor role that reports to the Director of Project Management , R&D, North America. The job duties for this… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Process Excellence Specialist III role ... is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell… more
