The posting
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
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
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $172,000.00 - $232,000.00 annually
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. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
