JOB FUNCTIONS/RESPONSIBILITIES
Must live in San Diego
Accountable for creating and implementing GXP inspection readiness strategy for the Company.
Identify inspection readiness goals, collaborate with cross-functional leaders to champion the process, collaborate with cross-functional leaders to identify and implement operational oversight and quality activities within clinical development in support of global inspection readiness.
Lead GXP global inspections, response strategy and development and execution of resulting CAPA plans.
Provide ICH/GXP expertise and consultative guidance related to business initiatives and lead GXP Quality initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Establish and manage GXP quality vendor oversight program and establish relationships with CRO Quality Team members for the ongoing review of quality and compliance metrics and issues.
Maintain a high level of expertise in global GXP regulations and internal policies and procedures that may impact clinical development.
Lead, develop and motivate a team of GXP Quality professionals.
Achieve established timelines within budget.
Manage GXP internal audits, as needed.
Manage and provide GXP Training Plan, provide content, trainer and/or training.
Work to establish and provide the programs GXP-QA metrics as needed
Must live in San Diego
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality