Regional Clinical Compliance Optimization Lead

BeOne Medicines Ltd.; Nederland; Hybrid; EUR 107,000 - 134,000; Full time

Job summary

BeOne Medicines Ltd. seeks an experienced Regional Clinical Compliance Optimization Lead to drive signals-based improvements across the EMEA region.

You will translate operational insights into compliant, scalable processes and partner with Global Clinical Compliance and RBQM to optimize trial execution. You will collaborate with Clinical Operations, Quality Assurance and global process owners, supporting regional implementation and training efforts while traveling up to 10% to partner with

Qualifications

• Bachelor’s degree in a scientific, medical or healthcare discipline with 10+ years in clinical research and clinical operations, plus 4+ years in a GCP compliance or equivalent role.
• Experience in data analytics, metrics and KPI management is preferred.
• Experience with RBQM, risk identification and data-driven decision making is preferred.

Responsibilities

• Identify signals and trends across EMEA using compliance data, audit findings, and operational insights.
• Translate insights into actionable improvements and work with Global Clinical Compliance and RBQM to enhance processes.
• Lead regional and country-level process improvements for efficiency, compliance and consistency.
• Collaborate with Clinical Operations, Quality Assurance and global teams; drive change management and adoption of new processes.
• Travel up to 10% as needed.

Skills

Signal detection

Trend analysis

Process improvement

Risk management

Operational excellence

Stakeholder collaboration

Change management

Data analytics

KPI management

RBQM

Education

Bachelor’s degree (BS/BA) in science/medical/healthcare

Tools

MS Office

Job description

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 Netherlands:

107,200.00 EUR - 134,000.00 EUR

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

Values:

Patients First

Driving Excellence

Bold Ingenuity

Collaborative Spirit

Equal Opportunity Statement:

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.

Company Overview:

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 11,000 colleagues spans six continents.

Additional Information:

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit