- Bristol Myers Squibb (Summit, NJ)
- …SDLC regulations, including 21CFR part 11, computer systems validation requirements , and good documentation practices. + Advanced understanding of pharmaceutical, ... discipline is required. + Minimum of 5 years' experience in an FDA -regulated industry. + 2 years' experience in a quality assurance-related discipline preferred.… more
- Stanford University (Stanford, CA)
- …research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements , and Good Clinical ... Cancer Clinical Research Manager - GI Oncology (Hybrid) **School of Medicine,...studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug… more
- Medtronic (Los Angeles, CA)
- …regarding FCAs - Serve as a regulatory expert, interpreting and applying complex requirements from agencies ( FDA , EU MDR, Health Canada, TGA, etc.), and ... **A Day in the Life** Position Overview: The Senior Manager , Field Corrective Actions is responsible for leading and...Actions / Recalls + Expert knowledge of global regulatory requirements (eg, FDA 21 CFR 806, EU… more
- Actalent (Vernon Hills, IL)
- …potency, purity, and identity data, managing method transfers, and ensuring compliance with FDA , USP, and ICH guidelines. The manager will provide technical ... Job Title: QC Manager Job Description The QC Manager ...SOPs, deviations, and CAPA processes. + Ensure cGMP compliance ( FDA , USP, ICH, ISO). + Oversee equipment validation/calibration, and… more
- LifeCenter Northwest (Bellevue, WA)
- …patient safety risk reduction strategies while aligning practices with CMS, OPTN/UNOS, FDA , AATB and other applicable regulatory requirements and best practices. ... Ensure compliance with CMS Conditions for Coverage, OPTN/UNOS bylaws and policies, FDA regulations, AATB standards and other applicable requirements relevant to… more
- Endo International (Raleigh, NC)
- …standard we live by every day. **Job Description Summary** The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is ... activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical… more
- J&J Family of Companies (Santa Clara, CA)
- …activities. + Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. + Other duties as assigned. ** Requirements ** + Bachelor's ... & Johnson is hiring for a **Post Market Surveillance Manager - Shockwave Medical** to join our team located...+ Ensure compliance of the Complaints System to internal requirements and Domestic and International Regulations. + Ensure compliance… more
- Fujifilm (College Station, TX)
- …TheSr. Manager -Facilities SupportOperationsunder theleadershipoftheDirectorof Facilitieswillberesponsibleformanagingthe dailymaintenanceoperationsincludingthe ... Functions:_** + Accountableas a system ownerfor themanagement,andoperationofthe BlueMountainRegulatory Asset Manager (CCMS/CMMS)across multiple facilities. + Responsibleto workwitheQMS(system administrators) when… more
- Dana-Farber Cancer Institute (Boston, MA)
- …deviation, violation, exception, or other event reporting. Ensure various regulatory reporting requirements are met, Study Sponsor, FDA , IRB, etc. + Serve ... studies to the IRB as well as assist with FDA submissions and IND management. Reporting to the CTIP...Associate Director for the Pediatric unit, the Regulatory Operations Manager (ROM) will oversee the CTIP Regulatory Unit, manage… more
- Endo International (Greenville, IL)
- …ensure that they operate in accordance with established procedures and regulatory requirements . + Ensures FDA , EU, and International Regulatory inspection ... standard we live by every day. **Job Description Summary** The Plant Quality Manager directs the operation of the Greenville Quality Department to ensure product… more