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.