- Gilead Sciences, Inc. (Foster City, CA)
- …presentation materials to ensure consistency and currency. + Manages internal logistics during Inspections , Mock inspections , or Audits of Gilead and ... processes and activities, including policies, procedures, and training related to inspections . + Responsible for inspection record archival and maintenance… more
- Rhythm Pharmaceuticals (Boston, MA)
- …documentation life cycle, Rhythm's validated electronic system that houses all of Rhythm's GxP records. The Associate Director QA will lead the Quality and ... a subject matter expert (SME) for areas of responsibility during regulatory inspections , and directly manage inspection readiness activities. + Support Quality… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …information flow at the GPT/ Clinical Operations level based on audits , inspections , regulatory intelligence, effectiveness checks and process improvement. ... and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic...proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for… more
- J&J Family of Companies (Titusville, NJ)
- …Develop and recruit diverse talents. + Accountable for TS&E processes, including Audits & Inspections , Temperature Excursion Assessment, and Temperature related ... Associate Director , Temperature Strategy & Execution - 2406177829W **Description**...therapies during all phases of clinical trials, consistent with GxP guidelines. You will develop and implement new solutions… more
- CSL Behring (Pasadena, CA)
- …Gene Therapy products. + Ensure regulatory compliance with cGMP, GSP, and other GxP requirements. + Lead tactical aspects of inspection readiness activities ... responsibilities for R&D Cell and Gene Therapy Product Development + Conduct internal audits of R&D areas as they relate to pre-Clinical trial materials and clinical… more
- Amgen (Thousand Oaks, CA)
- …and with technical and large system implementations + Experience in supporting inspections or internal audits and Safety Information tracking and ... can be proud of. **Global Safety Application Development - Director ** **Live** **What you will do** Let's do this....Good knowledge of IT systems and quality requirements for GXP compliant systems + Create insightful and progressive functional… more
- Novo Nordisk (Plainsboro, NJ)
- …Support processes, including but not limited to ISOtrain, Document Control, and/or Audits and Inspections , as necessary Physical Requirements 10-20% overnight ... in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN Quality departments.… more