- Charles River Laboratories (Shrewsbury, MA)
- …documentation. * Review documentation of functions performed as part of quality control requirements. * Perform study preparation activities including collection ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Bristol Myers Squibb (Devens, MA)
- …these efforts with site and global stakeholders across manufacturing, quality , supply chain, information technology, facilities, manufacturing science & technology, ... deliverables are completed on time and in alignment with Quality standards. + Lead the development of integrated timelines,...+ Lead planning and communications for cutovers to ensure regulatory and cGMP compliance. + Conduct lessons learned with… more
- Charles River Laboratories (Shrewsbury, MA)
- …Procedures (SOPs). * Review documentation of functions performed as part of quality control requirements. * Perform quarantine & isolation procedures as they relate ... with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling… more
- Charles River Laboratories (Shrewsbury, MA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... + Ensures that all customers are provided with high quality care and attention throughout the sales and service...Provides on-going support to resolve application related and image quality concerns on both a product and system level.… more
- Stantec (Boston, MA)
- …us create buildings that matter to our world. Together, we are enhancing the quality of life globally through design. Join us and design your place with Stantec. ... related to bio-pharmaceutical dosage forms, nutraceutical facilities and other regulated FDA or similar facilities where drug products are manufactured, stored in… more
- Sanofi Group (Cambridge, MA)
- …+ Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development. + Provide medical ... in which pharmaceutical organizations function including but not limited to FDA , OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR). + Oversee conduct of all clinical studies in… more
- Norstella (Boston, MA)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... manage plan renewals, negotiate service agreements and ensure cost-effectiveness and quality of services. + Develop and execute employee communications and education… more
- Cognizant (Boston, MA)
- …systems. + Manage Computer System Validation (CSV) activities in alignment with global regulatory standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline ... Life Sciences domain. You will be a valued member of the Quality Engineering & Assurance team and work collaboratively with cross-functional stakeholders including… more
- Tufts Medicine (Boston, MA)
- …transfusion medicine practice and familiarity with blood banking and cellular therapy regulatory requirements (ie AABB/CAP, FDA , FACT). + Committed to teaching ... Medicine brings together providers and organizations with a shared vision of high- quality care delivered in the setting that serves our patients best. Together,… more