Find & Apply For Clinical Quality Manager Jobs in San Mateo, California

• 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 InspectionsAll 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.