- Fujifilm (Holly Springs, NC)
- …and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, ... procedures to align with FDB Large Scale Biologics platform operating principles and regulatory requirements. * Ensures compliance with 21 CFR Parts 11, 210,… more
- Sumitomo Pharma (Raleigh, NC)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...critical role in supporting the tax department in meeting compliance , provision, and planning goals. The position is primarily… more
- Lilly (Concord, NC)
- …Manufacturing Practices (cGMP), including good documentation practices (GDP), data integrity and regulatory compliance + Fosters a strong quality culture by ... and cross-functional teamwork is essential for ensuring a constant state of cGMP compliance , as well as ensuring regulatory approval of the Concord facility… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …medical device, digital health, and AI clients on the application of healthcare regulatory laws to their business. The position will report to the Executive ... inside and outside the department. All members of OPH Legal and Compliance must exemplify collaborative culture and drive joint accountabilities across multiple… more
- Novo Nordisk (Durham, NC)
- …within the assigned process + Provide coaching to Site regarding quality & compliance related activities + Facilitate sharing of regulatory & compliance ... for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our… more
- Sumitomo Pharma (Raleigh, NC)
- …in biotech or pharmaceutical drug development. + Experience in interaction with regulatory agencies such as the FDA, EMA/CPMP, PMDA, or others. + Experience in ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- ThermoFisher Scientific (Greenville, NC)
- …Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ... relevant work experience. + 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with...and other program elements to maintain a state of regulatory compliance . + Help sites resolve challenges… more
- Lilly (Durham, NC)
- …strategies across the internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical ... and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices. +… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Verifies laboratory equipment and associated equipment logs to ensure proper operation. Compliance : + Maintain current knowledge of regulatory and industry ... is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company. POSITION SUMMARY: The QC Microbiology/EM Team Lead provides… more
- Sumitomo Pharma (Morrisville, NC)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...role. The Manufacturing Manager will ensure production readiness and compliance initiatives are optimized and executed appropriately in GMP… more