Key Responsibilities
* Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed.
* Work in collaboration with Global Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations.
* Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s).
* Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.