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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