BeiGene
Senior Director, GCP Inspection Management
BeiGene, Emory, Texas, United States, 75440
Job Description:
General Description:The Senior Director, GCP Inspection Management, 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 global risk-based, proactive GCP Inspection Strategy.
Ensuring 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.
Ensuring 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 Global GCP Inspection Strategy.
Lead a team of global 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 IR strategy.
Oversee (pro-actively) the adequate and timely fulfillment of all global inspection commitments, timely communication with international 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 administer 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.
Qualification Required:Education Required:
Bachelor’s degree, preferably in Science.
Experience:
15+ years of experience in the pharmaceutical/biotechnology industry.
10+ years of experience supporting GCPs and managing/hosting GCP Inspections.
Computer Skills:
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Other Qualifications:
Excellent verbal and written communication skills.
Ability to effectively collaborate in a dynamic environment.
Travel:May require up to 30% travel.
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General Description:The Senior Director, GCP Inspection Management, 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 global risk-based, proactive GCP Inspection Strategy.
Ensuring 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.
Ensuring 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 Global GCP Inspection Strategy.
Lead a team of global 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 IR strategy.
Oversee (pro-actively) the adequate and timely fulfillment of all global inspection commitments, timely communication with international 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 administer 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.
Qualification Required:Education Required:
Bachelor’s degree, preferably in Science.
Experience:
15+ years of experience in the pharmaceutical/biotechnology industry.
10+ years of experience supporting GCPs and managing/hosting GCP Inspections.
Computer Skills:
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Other Qualifications:
Excellent verbal and written communication skills.
Ability to effectively collaborate in a dynamic environment.
Travel:May require up to 30% travel.
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