- 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
- 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
- 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
- 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
- Bayer (Ankeny, IA)
- …key performance indicators to prioritize action, guide investigations, etc.) and conducting risk assessment & cost/benefit analyses; Skilled in organizing and ... will be reviewed and must meet guidelines based on the company's Risk Screening for Hiring Drivers.) Preferred Qualifications: Bachelor’s degree or master’s degree… more
- Cipla (Hauppauge, NY)
- …qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure ... modes, effects, and criticality analysis) Education Qualifications A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required. Experience 2-5+ years' experience Skills/ Competencies Proficiency with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …such as Quality, Safety, Compliance, IT based on business understanding and risk assessment ; collaborate with requesting business stakeholders as needed Triage ... in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME… more
- Eisai, Inc (Nutley, NJ)
- …performance and reduce potential risks.Oversees vendor qualification and collaborate with Vendor Risk Assessment teams to ensure vendor strategies comply with ... issues and mitigate risks.Process Management Drives functional strategy and risk management initiatives.Develops competency models and designs training and… more
- Cipla (Central Islip, NY)
- …etc. Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices (cGMP) and GLP ... systems both manual and automated. Follow all safety procedures and guidelines to ensure a safe laboratory environment. Prioritize risks and work with IT, QA, laboratory personnel to mitigate data integrity gaps. Partnering with other members of the Quality… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... Culture, Manufacturing Processes, Mentorship, Metabolomics, Molecular Biology, Omics Technologies, Process Characterization, Project Leadership, Project Management, Proteomics, Scientific Leadership {+ 3 more}Preferred Skills: Current Employees apply HERE… more
- Bayer (Myerstown, PA)
- …support process optimization and troubleshooting.Contribute to the development of project risk assessment , technical success criteria, Target Product Profile ... (TPP), and contingency plansfor development activities. Lead development of critical process parameters.Provide technical leadership to the BCH enterprise for the assigned technology.Stay updated with industry trends, technological advancements, and regulatory… more
- Insmed Incorporated (NJ)
- …and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports ... and development compounds and manage the ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … risk problems, providing guidance to leadership including trade-off and implications assessment (value, risk , cost, time) to the project or program.Prepares ... the interdependent deliverables for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Cipla (Fall River, MA)
- …developments leading to development of commercial models. Lead and implement a risk -based approach towards assessment of projects, project milestones and stage ... chain management and regulatory affairs, responsible for launch planning, launch risk mitigation and launch supply readiness. Responsible for collaborating with… more
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