About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
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.
Job Description:
General Description:
The Director, Regional Clinical Compliance and Inspection Management, is responsible for driving proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials. The role provides leadership and oversight to ensure consistent implementation of GCP and regulatory requirements, effective inspection readiness programs, and successful management of inspections and audits.
Key responsibilities include leading inspection readiness and audit support activities at regional or global levels, guiding clinical teams on inspection expectations, coordinating audit and inspection responses, and ensuring timely, high-quality, and compliant remediation. The role also drives a proactive inspection/audit readiness culture, to effectively manage complex, high-risk inspections while maintaining continuous readiness.
This role supports inspection and audit management across the JAPAC region, working in close collaboration with the Regional Clinical Compliance Head, who serves as the primary point of contact with Global Clinical Compliance (GCC). The role facilitates effective communication, alignment, and implementation of GCC strategies and initiatives within the region.
Essential Functions of Job:
Oversight of Inspection & Audit Portfolio
- Oversee high-risk and high-visibility inspections globally/regionally and Ensure consistency and quality across inspection handling
- Provide directions for preparation, execution, and response
- Intervene in complex or critical inspection scenarios
Inspection readiness and oversight
- Lead inspection readiness across the JAPAC region, ensuring alignment with global compliance requirements and GCO strategy.
- Drive implementation of inspection readiness standards, tools, frameworks, and best practices in partnership with GCC and RDQA
- Aligning regional activities with global compliance requirements and drive implementation of standards, tools, and best practices
- Ensure inspection readiness through training, guidance, mock inspections, and readiness assessments
- Assess inspection risks, oversee mitigation plans, and maintain inspection-ready documentation, processes, and systems
- Develop and maintain regional storyboards aligned with global templates, providing GCO SME support for content development
- Coordinate inspection logistics, briefing materials, and stakeholder alignment
- Conduct Site Compliance Visits for high-risk sites (On Site, Remote and Desktop reviews)
- Identify and analyze signals, trends, and systemic issues across JAPAC using compliance-generated data, audit findings, inspection outcomes, and operational insights.
- Translate aggregated insights into meaningful risk patterns and improvement opportunities.
- Provide regular reporting and recommendations to stakeholders to support informed decision-making.
- Propose and support process improvements based on identified trends and systemic issues.
- Support regional and country-level process improvement initiatives in JAPAC to enhance efficiency, compliance, and consistency.
Inspection and Audit Preparation, Execution and Follow up
- Lead regional preparation activities for regulatory inspections and internal/external audits
- Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)
- Align with Regional Clinical Compliance Head to conduct targeted site preparation visits where required
Inspection/Audit Execution
- Serve as the senior escalation point and executive liaison during regulatory inspections and audits within Clinical ompliance
- Support senior-level engagement with regulatory authorities and ensure aligned messaging, risk positioning, and response strategies
Post-Inspection/Audit Activities
- Lead and coordinate responses to inspection/audit findings and ensure sustainable corrective actions and delivery of regulatory commitments
- Oversee CAPA management, including risk assessment, root cause analysis, effectiveness checks, and timely closure
- Monitor trends, drive continuous improvement, and strengthen inspection readiness through lessons learned and partner cross-functionally to promote consistent, high-quality inspection outcomes
Core Competencies, Knowledge and Skill Requirements:
- Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
- Excellent analytical, problem-solving, quality management skills and high attention to detail
- Strong communication, stakeholder management, and influencing skills, including senior leadership engagement
- Demonstrated leadership in complex, global environments
Communication & Interpersonal Skills:
- Good English written and verbal communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Ability to foster collaborative working relationships
- Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment
Supervisory Responsibilities:
- Serves as a GCP expert to the Clinical Operations JAPAC with excellent working knowledge of ICH/GCP, regional regulations, SOPs and Clinical Operations Work Instructions.
- Demonstrates a high level of clinical operations knowledge and strong analytical and managerial skills.
- Ensures appropriate escalation of quality issues, potential misconduct, and significant deviations to relevant stakeholders.
Qualification Required:
Education Required:
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with 12+ years in clinical research, clinical operations, plus mminimum 6 years’ experience in a GCP compliance or equivalent role* (i.e. quality) is preferred
Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
- Experience in CAPA development and tracking, inspections and audits, including mock inspections and mock interviews including leading risk-based inspection preparation programs
- Deep knowledge of ICH-GCP, regulatory requirements and Clinical trial processes end-to-end
- Experience in oncology global trials is preferred
Travel: up to 15-20% travel
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
In-house and external learning and development opportunities
Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
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