[Hiring] Director, GCP Inspection Management @BeiGene

Role 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.
• 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 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 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.

Qualifications

• 10+ years of experience in the pharmaceutical/biotechnology industry.
• Bachelor’s degree, preferably in Science, or MS with 7+ years.

Requirements

• 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.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Eligible for discretionary equity awards and participation in the Employee Stock Purchase Plan.
• Annual bonus plan for Non-Commercial roles and incentive compensation plan for Commercial roles.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. The recruiter can share more about the specific salary range for a preferred location during the hiring process.