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.
The Regional Clinical Compliance (RCC) Inspection Lead 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 is the main point of contact for inspection and audit management ensuring continuous communication with Global Clinical Compliance (GCC), enabling alignment and implementation of GCC strategies and initiatives within the EMEA region.
Essential Functions of Job:
Oversight of Inspection & Audit Portfolio
Inspection readiness implementation and oversight
Drive implementation of inspection readiness standards, tools, frameworks, and best practices in partnership with GCC and RDQA
Assess inspection risks, oversee mitigation plans, and maintain inspection-ready documentation, processes, and systems
Inspection and Audit Preparation, Execution and Follow up
Inspection/Audit Execution
Inspection & Audit Execution Leadership
Post-Inspection/Audit Activities
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:
Strong communication, stakeholder management, and influencing skills, including senior leadership engagement
Communication & Interpersonal Skills:
Supervisory Responsibilities:
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 minimum 6 years’ experience in a GCP compliance or equivalent role* (i.e. quality) is preferred
exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.
** Experience in management of inspections and audits is preferred
Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Travel: up to 15-20% travel
Salary Range Switzerland: 187,400.00 CHF - 234,200.00 CHF
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.
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Fosters Teamwork
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Provides and Solicits Honest and Actionable Feedback
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Self-Awareness
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Acts Inclusively
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Demonstrates Initiative
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Entrepreneurial Mindset
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Continuous Learning
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Embraces Change
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Results-Oriented
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Analytical Thinking/Data Analysis
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Financial Excellence
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Communicates with Clarity
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.
