- Merck & Co. (Rahway, NJ)
- …analytical and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and problem-solving ... Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial member of...a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and… more
- Cipla (Fall River, MA)
- …regulatory submission while closely working with regulatory teams. Prepare and review risk assessment (FMECA) for various facility, equipment, process and ... particular event etc. Prepare and review elemental impurities risk assessment and nitrosamine related risk assessment . Prepare audit reports, documenting… more
- Eisai, Inc (NJ)
- …and minimize risk .Manages vendor qualification processes and partner with Vendor Risk Assessment teams to ensure compliance with regulatory requirements and ... teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering cross-functional collaboration and… more
- Merck & Co. (Rahway, NJ)
- …related activities to go live with new equipment and infrastructure (eg Quality risk assessment , safety assessment , data integrity, change management, ... Company (eg our Company's Manufacturing Division) to build or risk -mitigate infrastructure Position Qualifications: Education Minimum Requirement: Bachelor's degree… more
- Syner-G BioPharma Group (Boston, MA)
- …support for improvement projects regarding processes and systems.Support or provide risk assessment and mitigation activities for process development, ... commissioning and qualification of facilities, utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of… more
- Insmed Incorporated (NJ)
- …compliance, and environmental protection for all Insmed locations.Key duties include risk assessment , developing safety policies, managing training programs, and ... all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office settings.… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, ... strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene therapy programs. This individual will… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... and resources they need to succeed. Creating and implementing risk -based quality strategies that identify and address potential quality...record in their application and risk mitigation Proven experience in establishing and managing a… more
- Bayer (Whippany, NJ)
- …development and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. ... Reviews the testing/validation of AI. Prepares an AI risk mitigation plan (as needed). Enforce relevant QSDs/LQSDs, documentation and training. Organization… more
- Merck & Co. (North Wales, PA)
- …supply of direct and indirect materials, performing the supplier relationship management, supply risk assessment with actions in place and regular tracking, and ... for strategic decisions.- This individual is able to identify and mitigate risk by leveraging existing policies/procedures. Results and Performance - The incumbent… more
