- Sanofi Group (Bridgewater, NJ)
- **Job title:** Pharmacovigilance Audit and Inspection Readiness Manager **Location:** Bridgewater, NJ **About the Job** We deliver 4.3 billion healthcare ... and their families. **Main Responsibilities:** Reporting to the Medical/PV Audit and Inspection Readiness Head,...in the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety … more
- CSL Behring (King Of Prussia, PA)
- …internal and Health Authority inspections with the appropriate R&D teams. Leadership of inspection readiness plans and action plans post- inspection . **4-** ... packaging and medical device development. Quality oversight and management systems for Pharmacovigilance is also given. The role is responsible for the leadership… more
- Amgen (Thousand Oaks, CA)
- …risk assessment methodology) + Support Safety and Global Development teams in GxP inspection readiness and inspection management activities. + Support Safety ... meetings and tracking through to closure. + Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs. + Data entry into the risk… more
- Gilead Sciences, Inc. (Seattle, WA)
- …support and resources to assigned groups, including - data, reporting, training, audit , inspection , risk assessment and deviation/ CAPA management support. You ... assigned functions, vendors or relevant to assigned R&D programs. + Collaborates with the Audit , Inspection and CAPA Management Team within R&D Quality & Medical… more
- Lilly (Indianapolis, IN)
- …, coordination, back room, front room, responses). + Communicate and ensure inspection readiness (for example, organization and availability of documents such ... to ensure compliance, quality oversight of business areas to integrate requirements, audit / inspection support and collaboration within quality and other areas.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …executing activities associated with the RDQ framework of audit and inspection management, inspection readiness , gap assessments, risk management and ... incident escalation. Partners with RDQ to develop plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda's… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other ... lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to...lead projects in support of quality objectives, and support inspection readiness activities + Act as a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and written reports + Respond to queries from internal stakeholders to support inspection readiness , external audits, regulatory submissions and staff training + ... medical devices as assigned. + Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating… more
- AbbVie (North Chicago, IL)
- …and R&D Quality, the team ensures continuous real time inspection readiness through identification of internal audit trends, knowledge management, and robust ... competent by conducting user testing to validate the material's effectiveness. + Inspection & Audit independently assesses compliance and quality of AbbVie… more