- Novo Nordisk Inc. (Plainsboro, NJ)
- …Health Canada), and escalating quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support. ... continuously improved to manage quality effectively across the organization Support audits and Health Authority inspections to ensure internal/external… 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …contact for GxP Learning and collaborate with SMEs across the organization for audits and external Health Authority (HA) inspections . + Lead and define the ... + Translating the Enterprise Learning Team's vision and strategy into execution of GxP learning initiatives and applying core competencies across the GxP … 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
- Catalent Pharma Solutions (Bloomington, IN)
- …and documentation of quality oversight + Responsible for the management of audits (internal and client) and regulatory inspections , commitments, and risk ... **Position Summary** The Director of Quality Systems is responsible for managing...A depth of FDA-facing experience in managing both internal audits and external audits and inspection… 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
- Ascendis Pharma (Palo Alto, CA)
- …systems. Responsible for performing GCP internal, vendor, and clinical trial site audits . Ensures GCP and GVP Inspection Readiness and continuous process ... marketing. This position is based in the US. The Director , GCP & GVP Quality is responsible for the...inspection readiness training, one-one practice sessions and mock inspections as needed. + Hosts or supports GCP &… 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
- Boehringer Ingelheim (Athens, GA)
- …(RPI) as requested to other departments within the company. + Supporting internal audits and regulatory agency inspections . As an employee of Boehringer ... with global regulations and laws. + Provides support during audits and authority inspections as needed. +...mining and signal detection + Experience working in a GXP /compliance driven environment subject to health authority inspections… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the vendor and/or cross-functional teams. + Participates and represents function in formal inspections and audits as requested. + Maintains SOPs, process maps ... to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Clinical Data Standards where you will be responsible for driving the… more
- AbbVie (North Chicago, IL)
- …personnel + Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers + ... regulated studies + Independently plan and conduct internal system audits and external GxP supplier audits...experienced level compliance position that reports to the Associate Director GxP Compliance. This individual is expected… more
