- 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
- Novo Nordisk Inc. (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
- 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
- Sumitomo Pharma (Morrisville, NC)
- …a prepared state of inspection readiness through training, leadership and inspection management during Agency inspections . + Lead the Quality representation ... **Sr. Director , Cell Quality** Sumitomo Pharma America (SMPA) is...based and combination product program teams. This role interprets GxP regulations, determines quality requirements, and works closely with… more
- CSL Behring (King Of Prussia, PA)
- **The Opportunity** The Senior Director I&T Risk and Compliance Management Services for CSL's technology function (I&T), develops and implements a comprehensive risk ... risk mitigation strategies, managing a team of professionals responsible for GxP activities, testing excellence, evaluation and ongoing management of third-party… more
- Actalent (Jersey City, NJ)
- …come in and identify gaps in their QA group + Vendor qualification + Site inspections + GCP/ GXP + Experience with global agencies where needed Experience Level: ... Our client is seeking an Associate Director or Director of Clinical QA...assessments to identify audit targets, conduct internal and vendor audits , develop and maintain audit tools, checklists and plans,… 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
- Randstad US (Norwood, MA)
- …are completed and maintained for use by the business and available to support audits or inspections . + Complete training in assigned required learning plan ... to 5 education: Bachelors responsibilities: Reporting to the Associate Director of Quality Control, the company is seeking a...and result entry. + Raw material and consumable component inspection and release. + Clean room gowning and aseptic… more
