Regional Clinical Compliance Inspection Manager

BeOne Medicines ESP, S.L.U.; España; Presencial; EUR 70.000 - 87.000; Jornada completa

Descripción de la vacante

BeOne Medicines ESP, S.L.U. is seeking a Regional Clinical Compliance Inspection Manager to drive proactive risk management and inspection readiness across clinical trials in the EMEA region.

You will lead inspections and audits, coordinate cross‑functional teams, manage CAPAs, and ensure timely, compliant remediation while upholding ICH-GCP guidelines.

Formación

• BS/BA or higher in a scientific, medical or healthcare field
• At least 5 years in clinical research, operations, or compliance
• Experience in GCP inspections and audits preferred
• Experience in oncology global trials preferred

Responsabilidades

• Lead inspection readiness and audit support activities regionally/globally
• Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)
• Manage CAPAs, root cause analysis, and effectiveness checks
• Drive remediation and continuous improvement of regulatory processes

Conocimientos

ICH-GCP knowledge

Analytical thinking

Stakeholder management

Communication

Multi-cultural workplace

Educación

Bachelor’s degree in science/healthcare

5+ years in clinical research/compliance

Herramientas

MS Office

Descripción del empleo

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 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 co-nduct 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 5+ 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:

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 20% travel

Salary Range Spain: 69,600.00 EUR - 87,000.00 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

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.