- Aequor (Tallahassee, FL)
- …QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority ... quality measures Ensure vendor compliance with approved processes and training requirements Audit & external inspection support Job Summary Responsible for:… more
- 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
- BeiGene (San Mateo, CA)
- … Management Teams and cross-functional compliance functions, in developing/adjusting adequate Inspection Readiness (IR) Plans and Strategies, based on review ... of available data/metrics. + Assisting R&D Quality audit functions in developing/adjusting the audit scope/strategy, based on review of data/metrics. + Assisting… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …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
- Takeda Pharmaceuticals (Boston, MA)
- …of Takeda's values and priorities. + Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy. Engage ... with relevant responsibilities and partners to ensure inspection readiness , driving accountability and transparency. Function include Global Development Office,… more
- System One (NY)
- …operations, strategic planning, and contribute to department leading effective operations and inspection , audit readiness . + As assigned: Working with ... and team communications, and initiatives associated with the science of pharmacovigilance in support of GPS departmental requirements. In collaboration with the… 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
