- Merck & Co. (Rahway, NJ)
- …understanding of Design Controls (21 CFR 820.30) Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, EU ... Method Validation, Microscopies, Product Development, Project Leadership, Prototyping, Quality Management , Rheometry, Risk Management , Statistical Analysis,… more
- Merck & Co. (Millsboro, DE)
- …environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote best ... knowledge of federal, state, and local biosafety regulations, and advise management accordingly.Review risk assessments for biological materials and laboratory… more
- Merck & Co. (Rahway, NJ)
- …Planning, Project Management , Project Procurement Management , Regulatory Compliance , Risk Management , Strategic Procurement {+ 5 more}Preferred ... and category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Investigator Compliance Specialist as part of the Technical Operations ... team based in Raritan, NJ. Role OverviewThe CAR-T Compliance Auditor ( Sr . Investigator) will be a...in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.The… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …Pharma. This position will focus on the recognition , evaluation, and control of EHS risk at the facilities and the overall compliance of the site to EPA, ... and work to build a strong culture of EHS compliance at the site to support and protect the...processes Managing site safety & security procedures to include management of the badge system for employees, temps, contractors,… more
- Insmed Incorporated (NJ)
- …to apply risk -based approaches, maintain validated state, and drive continuous compliance in support of patient safety and product quality. The position requires ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...either our Bridgewater, NJ or San Diego location. The Sr . Quality Engineer, Digital Systems Quality Assurance (QA), is… more
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical method ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for...future of science, we're in. Are you?About the Role:The Sr . Director CMC QA will lead QA CMC oversight… more
- Merck & Co. (Rahway, NJ)
- …The engineer will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices ( c GMPs), and ... participating in risk assessments, deviation investigations, and Good Documentation Practices (GD...solving skills. - Good organizational, interpersonal, writing, and time management skills - - Preferred Experience and Skills: -… more
- Insmed Incorporated (NJ)
- …and emerging risks that impact public company reporting and internal controls.While Compliance maintains broadly Enterprise Risk Management (ERM), Internal ... of SOX requirements, internal control framework (COSO), GAAP and risk management methodologies.Excellent analytical, problem-solving and critical thinking… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic ... favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (North Wales, PA)
- …to support the EDSA review process. Manages programs (patient support, educational or risk management ) to support appropriate and safe utilization of Our Company ... Job Description Role Summary: The Global Senior Director Medical Affairs (GDMA) is a subject...skills (written and oral) in addition to results-oriented project management skillsPreferred: At least 3 years regional medical affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight across all Medical Affairs programs. This role involves deputizing for the Sr . Director, representing the Quality organization at senior levels. The ... with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through...to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance … more
- Merck & Co. (Rahway, NJ)
- …other domestic locations or international opportunities where mutually desirable.-Additionally, senior management exposure, mentoring, networking and other ... not limited to, forecasting, reporting, and analyzing operating results; operational risk management and process improvement consulting; managing capital… more
- Eisai, Inc (Nutley, NJ)
- … Risk Management , Mentoring/ People Development, Stakeholder Management (Legal/ Compliance )Eisai Salary Transparency Language:The base salary range ... new system implementations, including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program… more
- Merck & Co. (Rahway, NJ)
- …design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change ... process and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and… more
- Merck & Co. (Durham, NC)
- …technically strong individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple ... Mitigated Risks, Multi- Management , People Leadership, Physical Sciences, Production Management , Project Management , Regulatory Compliance {+ 2… more
- Merck & Co. (Rahway, NJ)
- …and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies and practicesTechnology Management Design and ... Migrations, Deal Management , Detail-Oriented, Generative AI, Information Systems Management , Information Technology (IT) Risk Management , Intellectual… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Nevada System of Higher Education (Las Vegas, NV)
- …assurance and advisory services that evaluate and improve the effectiveness of risk management , internal controls, compliance , and governance processes ... to produce clear audit reports and deliver findings to senior management and the Board.Project management...and stay current on emerging trends in internal auditing, risk management , and higher education compliance… more