- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …research-based pharmaceutical company. POSITION SUMMARY: Under the direction of the Senior Manager , Quality Compliance , the Quality Compliance Specialist is ... Quality Compliance Specialist Department: Quality Location: Monroe, NC START...Skills : Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH… more
- Amgen (Holly Springs, NC)
- …Experience in new facility start-up or tech transfer projects + Expertise in global regulatory requirements ( FDA , EMA, etc.) + Strong background in laboratory ... utilities and office space. Amgen is targeting 2024 for site completion. Senior Manager Quality Control Support **What you will do** Let's do this. Let's change… more
- BioLife Plasma Services (Raleigh, NC)
- …exceptional customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and ... application is true to the best of my knowledge. **Job Description** ** Manager Trainee - Operations (Travel Program - Relocation Required)** **Position is based… more
- Kelly Services (Clayton, NC)
- …laboratory. The position oversees quality systems, documentation, laboratory operations, regulatory compliance , employee development, staffing, training, and ... **Position Title:** Quality Control Environmental Monitoring Manager **Location:** Clayton, NC **Schedule:** Monday - Friday...+ Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/GxP) + Budget planning and… more
- Honeywell (Charlotte, NC)
- …transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, ... critical challenges including technology transfer, batch execution, quality management, regulatory compliance , and operational efficiency. **Key Responsibilities**… more
- Merck (Raleigh, NC)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- ThermoFisher Scientific (Wilmington, NC)
- …activities, and ensure that essential document quality meets the expectation of Regulatory Compliance Review. Ensure timely regulatory submissions (if ... Name: PPD Development, LP Position Title: Senior Clinical Team Manager Salary: $139,207.70 per year Location: 929 North Front...of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific… more
- Sumitomo Pharma (Raleigh, NC)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Sumitomo Pharma (Raleigh, NC)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Teleflex (Morrisville, NC)
- …as required by facility requirements. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian ... Clinical Affairs Manager (REMOTE) **Date:** Aug 11, 2025 **Location:** Morrisville,...support to clinical end-users, clinical sales specialists, sales team, Regulatory , Engineering, marketing, and other corporate departments on safe… more