- Gilead Sciences, Inc. (Foster City, CA)
- …and continuous improvement. + Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards. + Maintain compliance with ... certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager ) or equivalent. + Familiarity with emerging regulatory requirements… more
- Seattle Children's (Seattle, WA)
- …the areas of clinical trial operations and 5 years in a leadership/ manager role with increasing responsibility overseeing early phase oncology trials; developing, ... implementing, and leading early-phase (I/II) clinical trials. and FDA regulations and guidelines including the IND Direct experience managing early phase cell, gene… more
- UnityPoint Health (Dubuque, IA)
- …for 80 hours per pay period The Risk Management and Accreditation Program Manager serves as a highly visible champion of regulatory compliance and managing clinical ... of professional organizations such as DNV, OSHA, Food and Drug Administration ( FDA ), etc. + Manages regulatory agency survey process, post survey action plans… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and semi-regulated countries. POSITION SUMMARY: Under the direction of the Director/ Manager , Quality Systems, the Quality Systems Specialist is responsible for ... Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical… more
- Abbott (Abbott Park, IL)
- …lessons learned and continuous improvement initiatives. + Oversee Construction Manager (CM) performance. + Coordinate with design, engineering, validation, ... + 5-10 years of experience in construction engineering, preferably in FDA /ISO regulated environments. + Strong understanding of construction methods, codes, and… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... and cost saving initiatives). + This role requires a skilled senior manager with pharma engineering experience, compliance and safety focused. + Strong operational… more
- Danaher Corporation (Miami, FL)
- …Assurance, and Technical Support. This position reports to the Senior Manager of Global Service Compliance, Technical Publications and Digital Solutions in ... content for consumables product labeling. . Manage new labeling projects to meet FDA , EU, IVDR, ISO, CLP/GHS, and other countries' regulatory requirements. . Support… more
- Cardinal Health (Indianapolis, IN)
- …properly reviewed for quality and documented. **_Job Summary_** + Reports to Manager , Quality Assurance. + QA Principal Specialist is responsible for ensuring ... in the release of the final product in compliance with applicable regulations ( FDA , EU, etc.) and marketing authorizations. + Responsible for the review and… more
- US Tech Solutions (Mettawa, IL)
- …create new and update existing **digital and print marketing materials** within FDA regulations and set priorities with project managers to meet critical deadlines ... week. Nice to Have, but not required * Experience working in **Knak, Adobe Experience Manager , and eWizard** (You'll learn how to use this software on the job). *… more
- Lactalis American Group Inc. (Nampa, ID)
- …to ours Key responsibilities for this position include + Assists the department manager to enhance the technical and financial performance of the department. + ... . Experience in Food industry preferred. Specialized Knowledge . OSHA, Food Safety, FDA and USDA. . Knowledge of ISO and certifications within the food industry… more
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