- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Knowledge and Skills : Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as ... pharmaceutical company. POSITION SUMMARY: Under the direction of the Senior Manager , Quality Compliance, the Quality Compliance Specialist is responsible for… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product , Trimbow(R). We want ... of key initiatives. + Work along and lead marketing manager to develop product positioning, messaging, and...and an eye towards innovation. + Ensure compliance with regulatory , legal, and corporate requirements both separately and for… more
- Reynolds American (Winston Salem, NC)
- …countries with over 55,000 employees. The GGP prepares you for a Lead Manager role within one year, with international career opportunities across BAT's footprint. ... of two primary areas: Scientific Research & Development (SR&D) and Scientific and Regulatory Affairs (S&RA). Within these spaces you could work in various spaces… more
- Kedplasma (Hickory, NC)
- …and storage of plasma collected from donors under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice and ... FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...AND RESPONSIBILITIES** **Core** + Maintains safety and integrity of product and samples during processing, storage, and shipment release… more
- Fujifilm (Raleigh, NC)
- …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... the Endoscopy space. The role of the Business Development Manager is to understand and define our internal and...marketing organization. The incumbent is responsible for supporting the product management group including, but not limited to market… more
- Cambrex High Point (Durham, NC)
- …as analytical development and method onboarding workflows for drug substance and drug product . Reporting to the ( Manager , Associate Director, or Director), the ... and (where required) development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: Under the direct supervision of the ... ** ** **Summary:** Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with internal… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... The Lead Project Engineer (PE) oversees all technical aspects of Synapse product implementation, from solution validation phases through product go-live.. Lead… more
- RELX INC (Raleigh, NC)
- …You'll guide a small team of engineers and work side-by-side with a senior product manager to define, build, and iterate on early-stage concepts. About the ... ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives...autonomy, innovation, and rapid iteration. + Collaborate with the product manager to shape roadmaps, scope experiments,… more
- ThermoFisher Scientific (Greenville, NC)
- …Position will support to the Greenville, NC, site and will report to the Sr Manager , Validation. The Drug Product Division - North America (DPD-NA) is one of ... validation liaison, negotiating with clients on agreements and resolving significant validation, product , and regulatory issues. **A Day in the Life:** +… more