Address
Form of workMust have 10+ Years ofrelevant experience
- Lead the Ramp;D Quality and Manufacturing team to manage GCP (good clinical practice) and GPV (good pharmacovigilance practices) inspections by global regulatory health authorities.
- Provide strategies and oversight for global planning-preparations and clinical investigations.
- Build systems and tools to support and oversee end-to-end inspection readiness and inspection management training.
- Develop staff competencies and capabilities in inspection readiness, inspection conduct, and CAPAs. nbsp;Collaborate with teams and SMEs to investigate and resolve inspection readiness gaps prior, during and post inspection. nbsp;Support CAPA development and perform CAPA effectiveness checks for inspection findings.
- Contribute regulatory and quality strategies for the preparation of inspection risk assessments for senior management and key stakeholders.
- Review QMS (Quality Management System) policies and processes for inspection readiness
- Provide as-needed liaison to client’s partner and vendor inspections.
WorkSchedule
- Full time (40 hrs/week)
- 4 days/week on-site
- Remote for remaining time
- Location: San Francisco Bay Area
- Duration: 6 months
