Regional Clinical Compliance Optimization Lead

BeOne Medicines; Basel; Vor Ort; CHF 156.000 - 195.000; Vollzeit

Zusammenfassung

BeOne Medicines seeks an experienced Regional Clinical Compliance Optimization Lead to drive continuous improvement in clinical trial execution across the EMEA region. You will identify signals, trends, and systemic issues, translating insights into actionable improvements in collaboration with Global Clinical Compliance and RBQM teams.

The role requires a BA/BS in a scientific field, 10+ years in clinical research with at least 4 years in a GCP compliance or quality function, plus experience in

Qualifikationen

• Requires bachelor's in scientific/medical field with 10+ years in clinical research.
• Exceptions may be made for equivalent experience in Clinical Operations.
• Experience in data analytics, metrics and KPI management is preferred.

Aufgaben

• Identify signals, trends, and systemic issues across EMEA using compliance data, audit findings, inspection outcomes, and operational insights.
• Translate insights into meaningful risk patterns and improvement opportunities.
• Provide regular reporting and recommendations to stakeholders for informed decision-making.
• Propose and support process improvements based on identified trends and systemic issues.
• Collaborate with RBQM teams to integrate findings into process risk assessments and mitigation strategies.
• Ensure alignment of improvements with GCP requirements and quality standards.
• Identify training needs and support for regional education sessions.

Kenntnisse

RBQM principles

Data analytics

Process improvement

Quality management

Stakeholder management

Ausbildung

Bachelor’s degree in science/medical field

Tools

MS Office

Jobbeschreibung

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 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 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

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.

Global Competencies

• 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.