- Insmed Incorporated (Bridgewater, NJ)
- …Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices ( GVP ) and other related ... strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to… more
- Ascendis Pharma (Palo Alto, CA)
- …with subject matter experts and senior management to formulate responses to audit /inspection findings relevant to GCP and GVP . + Responsible for the ... risk-based Quality Strategy, and maintenance of vendor qualification, global GCP and GVP processes, standards, and compliance monitoring systems. Responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …and audit program, quality agreements and governance. + Serves as a senior strategic Quality Partner to various Compliance functions in Data Science ... the internal audit program of the clinical research (GCP), pharmacovigilance ( GVP ) and medical processes and systems across the enterprise. + Sets the strategy,… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide mentorship and ... leadership for all aspects of quality and compliance . The incumbent will engage with key collaborators, build strategic partnerships working and collaborating… more
- Lilly (Indianapolis, IN)
- …and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance , Legal, and Ethics and Compliance ; and third-party organizations ... is responsible for partnering with Cell & Gene Therapy Senior Management within discovery, research, product development and manufacturing...and ensure operation in a manner such that all GCP/ GVP activities are followed. + The Sr Director is… more
