Director, GCP Inspection Management- Americas
BeiGene
Summary
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.
Job description
Essential Functions
- 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 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
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
Computer Skills
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
Travel
May require up to 30% travel
Requirements
- 10+ years of experience in the pharmaceutical/biotechnology industry
- 5+ years of experience supporting GCPs and managing/hosting GCP Inspections
- Bachelor's degree, preferably in Science, or MS with 7+ years
- Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials
- Proven ability in setting strategy for and driving quality process improvement initiatives
- Strong leadership experience, strategic, analytical and mentoring skills
- Strong judgment, project management and decision-making skills
- Excellent verbal and written communication skills
- Ability to effectively collaborate in a dynamic environment
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual bonus plan
- Discretionary equity awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.