- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Deep expertise in the implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud ... Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the oversight, performance, and management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tools to achieve excellence in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational ... support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored… more
- Insmed Incorporated (San Diego, CA)
- …a fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... Manager , you will be responsible for the daily oversight...stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other… more
- Aequor (Thousand Oaks, CA)
- …The position must work closely with Environmental Health Safety Services (EHSS) and Quality Assurance (QA) for compliance . The position will support the projects ... to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. ... trouble shooting and resolving complex scientific / technical problemsDevelops and evaluates quality processes and system standards to ensure compliance with… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and 10 Essentials in all activities and interactions with othersSupport other quality compliance and implementation projects, as assignedOther Duties as ... a key player in the Deviation Response Team team and a champion for quality priority principles and compliance within the organization.This role is a full-time… more
- Novo Nordisk Inc. (WA)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Aequor (Thousand Oaks, CA)
- …taking into account the MSP fee) As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Lead, the Labeling ... Manager is responsible for supporting the facilitation and management...Advises internal and/or external experts on the creation of high- quality documents supporting changes to the core labeling documents… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell ... myeloma.Legend Biotech is seeking QA Lab Oversight Specialist as part of the Quality team based in Raritan. Role OverviewThe QA Lab Oversight Specialist role is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Warehouse Incoming/Raw Material ... Raritan, NJ Legend manufacturing site.Key Responsibilities Be part of the quality team responsible for incoming inspection/release of materials related to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.Work closely with operations ... the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.Support manufacturing investigations, create/revise operational… more
- Leidos (Reston, VA)
- …! **The Leidos Health Solutions Group is seeking a Portfolio Director supporting the FDA , located in the DMV area.** This position will report to the Health ... Solutions Division Manager , Vice President. The ideal candidate will provide oversight...or strategic programs) across the HHS Division, including policy compliance + Provide oversight to active programs on financial… more
- Arkema (Memphis, TN)
- Quality & Compliance Manager Job Location:...customer. The Manager ensures that the plant maintains compliance with all FDA (drug and food), ISO, ... 26, 2024 Division: Oxygenes & Derivatives Location: Memphis Title: Quality & Compliance Manager Situation in...for drug/food products. + Hosts /Manages customer and regulatory ( FDA , ISO, NSF, etc.) audits. Other responsibilities (10%) +… more
- University of Miami (Miami, FL)
- …at the University of Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance ... compliance with relevant regulatory standards and that the quality management system of the CRCMP complies with all...programs. + Conducts the preparation of research teams for FDA or other regulatory agency audits. + Assists research… more
- Reynolds American (Clarksville, TN)
- …live our ethos every day. Come be the change!** **WE ARE LOOKING FOR A QUALITY COMPLIANCE & PERFORMANCE SR MANAGER ** SENIORITY LEVEL: Mid-Senior Level ... Quality Performance & Compliance Sr Manager Reynolds American is...Quality , Manufacturing, Maintenance, Site GM **External** - Suppliers, FDA **Geographic Scope** LOCAL **Travel Required** 10% **WHAT YOU… more
