Regional Clinical Compliance Inspection Manager

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 Regional Clinical Compliance (RCC) Inspection Manager 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.  

 

Essential Functions of Job: 

 

Inspection readiness implementation and oversight 

Organize briefing materials, logistics, and stakeholder alignment 

Support inspection readiness across the EMEA region  

Support implementation of standards, tools, and best practices  

Ensure teams are inspection-ready through training and guidance  

Assess inspection risks and oversee mitigation plans  

Supports mock inspections and readiness assessments  

Maintain inspection-ready documentation, processes, and systems 

Supports development of story boards based on global story boards templates and structure and acting as subject matter expert (SME) in content generation together with the relevant functional area SMEs  

 

Inspection and Audit Preparation, Execution and Follow up  

Support regional preparation activities for regulatory inspections and internal/external audits 

Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)  

Align with Regional Clinical Compliance Lead to conduct targeted site preparation visits as required 

 

Post-Inspection/Audit Activities 

Lead and coordinate responses to inspection/audit findings  

Manage CAPAs, including risk assessment, root cause analysis, and effectiveness checks  

Track CAPAs to timely and effective closure  

Ensure robust root cause analysis and sustainable corrective actions  

Oversee CAPA strategies and regulatory commitments  

Drive consistent, high-quality organizational responses  

Monitor trends and identify opportunities for continuous improvement  

 

Core Competencies, Knowledge and Skill Requirements: 

Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines 

Analytical and problem-solving skills and high attention to detail, and quality orientation 

Excellent communication and stakeholder management skills 

Influence senior stakeholders and decision-making 

 

Communication & Interpersonal Skills:  

Excellent English written and verbal communication and interpersonal skills 

Excellent organizational skills and ability to prioritize and multi-task 

Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment  

 

Supervisory Responsibilities:   

Not applicable  

 

Education Required:  

Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with 10+ years in clinical research, clinical operations, or compliance 

Minimum 4 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) 

 

Other Qualifications:  

Experience in CAPA development and tracking  

Experience in inspections and audits management, including mock inspections and mock interviews 

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 

   

Salary Range Switzerland: 156,200.00 CHF - 195,200.00 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.

• 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

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.