Regional Clinical Compliance Optimization Lead

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)   Optimization   Lead   is responsible for   proactively   identifying   signals, trends, and systemic issues across   countries and   EMEA   region   to drive continuous improvement in clinical trial   execution and   processes. This role plays a key part in translating operational insights into actionable improvements, partnering with Global Clinical Compliance, RBQM (Risk-Based Quality Management), and global process owners to enhance efficiency, compliance, and quality across the organization.   Collaborates closely with RCC Inspection   Lead   and RCC   Lead   (including   Country RCCs   as needed).

Essential Functions   of the Job:

Signal Detection & Trend Analysis

- Identify   and   analyze   signals, trends, and systemic issues across EMEA 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.

Process Improvement & Risk Management

- Propose and support process improvements based on   identified   trends and systemic issues.

- Collaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies.

- Ensure alignment of improvements with GCP requirements, company procedures, and quality standards

- Identify   areas of   additional   training   and support   for   preparing and delivering such educational   sessions   within   the   EMEA region

Operational Excellence & Implementation

- Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.

- Act as a liaison between regional/country teams and Global Clinical Compliance and global process owners.

- Facilitate the   regional   implementation of improvements   identified   at   global,   local   or regional levels, ensuring scalability and sustainability.

- Promote best practice sharing across countries and regions.

Stakeholder Collaboration & Influence

- Partner cross- functionally   with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.

- Influence stakeholders at multiple levels to drive   the adoption   of process enhancements.

- Support change management activities related to new or updated processes.

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,   plus   m inimum   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 data analytics, metrics and KPI management is preferred

Computer Skills:   PC literacy   required ;   MS Office   skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:

- Experience with RBQM principles, risk identification, and data-driven decision-making.

- Experience in process improvement, operational excellence, or quality initiatives.

- Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus

- Experience supporting or implementing global process changes

- Experience   in oncology   global trials is preferred.

Travel:   up   to   10 %   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.