- Merck & Co. (Rahway, NJ)
- …conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk ... internal and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post-market surveillance, clinical… more
- Bayer (IN)
- …and engineering controls to maintain regulatory compliance and minimize HSE risk ; Lead cross functional safety committees, ergonomics teams, and/or project ... communicated, and managed; Establish and maintain accident prevention programs; lead incident investigations when incidents do occur, and drive corrective… more
- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls , draft ... the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Bayer (Whippany, NJ)
- …Participates in the development and configuration of AI including implementation of controls . Performs a formal risk assessment based upon the intended ... difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports… more
- Merck & Co. (Rahway, NJ)
- …- Principal Responsibilities Lead /Support continuous improvement initiatives for design control and risk management processes Identify and eliminate process ... responsible for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This… more
- Repligen (Waltham, MA)
- …" controls by design."Maintain ITGC narratives, process flows, and risk / control matrices.Identify and drive process improvements, automation opportunities, ... ComplianceWe are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls over… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Insmed Incorporated (NJ)
- …and environmental protection for all Insmed locations.Key duties include risk assessment, developing safety policies, managing training programs, and ensuring ... Insmed's Director of Environmental Health & Safety (EH&S), the individual will lead the development, implementation, and management of a company-wide EH&S program… more
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