Director, GCP Inspection Management- Americas

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 and in evaluating quality systems, processes, procedures, plans, and protocols for compliance
Proven ability in setting strategy for and driving quality process improvement initiatives
Strong leadership experience, strategic, analytical and mentoring skills
Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials
Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
Effective and balanced management skills in building and supporting highly effective teams
Computer Skills:

PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:

Communication & Interpersonal Skills
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
Significant Contacts

All R&D Quality Organizations
BGNE Quality Organization
Clinical Operations
Pharmacovigilance
Clinical Development
Clinical Business Operations
Biometrics
Medical Monitors
Regulatory Affairs
Interacts with all levels of BeiGene
BGNE Affiliates
Travel:

May require up to 30% travel
Education Required:

10+ years with Bachelor's degree, preferably in Science, or MS with 7+ years.
Experience:

10+ years of experience in the pharmaceutical/biotechnology industry
5+ years of experience supporting GCPs and managing/hosting GCP Inspections
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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