Director, GCP Inspection Management- Americas

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

The Director, GCP Inspection Management - Americas, is responsible for:

• Supervising activities related to inspection readiness, hosting and coordinating GCP inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
• Developing, maintaining and ensuring the execution of a risk-based, proactive GCP Inspection Strategy
• Ensure the development of inspection risk-analyses and risk-mitigation plans and communicating to relevant cross-functional and Quality Leadership
• Supervising/Managing the collaboration with cross-functional internal and external partners to ensure a unified, optimal inspection strategy
• Ensure the development, revision and maintenance of optimal tools, processes and procedures for inspection readiness, coordination and management.

Essential Functions of the job

• Ensure the creation and execution of the GCP Inspection Strategy
• Lead a team of Quality professionals and/ or consultants to carry out all defined GCP Inspection Readiness, Management and Hosting activities
• Collaborate with relevant cross‑functional leaders to ensure a unified, optimal Inspection Readiness (IR) strategy
• Oversee (pro‑actively) the adequate and timely fulfillment of all inspection commitments, timely communication with Inspectorates/Health Authorities, including responding to inspection findings and submission of inspection dossiers and pre‑inspection requests and resolve any issue for timely and adequate closure of CAPAs.
• Maintain an up‑to‑date inspection forecast and inspection outcome tracker
• Ensure the provision of lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.
• Chair quarterly Cross‑functional Inspection Oversight Committee (IOC) meetings
• Guide and / or manage the creation/revision of relevant procedures
• Manage / review trends and report significant investigation / deviation issues and system deficiencies to senior management, as appropriate
• Manage internal training program and coordinate and / or administered GxP training, as needed
• Participate and represent R&D Quality in meetings and discussions, as needed
• Act as R&D Quality Delegate for the Executive Director, R&D Quality, as needed
• Support development of metrics and measures for Inspection Data to drive assessment and continuous improvement
• Participate in budget forecasting, planning, and tracking; monitor and maintain activities to stay within budget
• Provide coaching and mentoring of team members with training / orientation / qualification of new Quality staff
• Promote continuous improvement
• Provide support with the GCP Inspection Management Team for other inspection types (e.g. GLP/GLP and PV inspections)
• Other duties as assigned

Supervisory Responsibilities

Ability to resolve complex problems where analysis of situations or data requires an in‑depth evaluation of various factors Effective and balanced management skills in building and supporting highly effective teams Strong global mindset and knowledge about regulations (specific expertise regulations/ requirements/ culture awareness) Promote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate SOPs Superb attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast‑paced environment Exercise sound and balanced judgment in ensuring that written procedures are followed…