Regional Clinical Compliance Director​/Senior Director - Studentjob.ch

Regional Clinical Compliance Director/Senior Director

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.

The Regional Clinical Compliance (RCC) Director/Senior Director is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Medicines Clinical activities at global, regional, country, site and/or study levels as applicable. In summary:

• Provides compliance oversight as well as quality support to BeOne GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
• Seeks opportunities to implement best practices, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
• Supports timely identification of non‑compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
• Tracks and trends non‑compliance issues, quality events, and any other relevant observations identified during Site Compliance Visits, to help identify issues and risks across BeOne study programs and processes. The job holder supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
• Adheres to ICH/GCP, local regulations, applicable BeOne SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.
• Demonstrates significant clinical study experience and understanding of investigational site setup, trial management, trial conduct at study & site level, as well as clinical operations processes.
• Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
• Supports inspection readiness, preparation, hosting, response management and further lesson‑learned development, as applicable.

• Provides team leadership, including guidance, oversight and GCP expertise to Regional Clinical Compliance stakeholders.
• Fosters a collaborative working relationship with key stakeholders (e.g. Regional and country study team members, global & regional clinical compliance, GCOE and GCO team members), to enable timely identification of potential problems, to ensure proper root cause assessments and corrective and preventative actions are in place.
• Supports Regional Clinical Compliance team through guidance in drafting responses and corrective and preventative action plans to internal/external audits and external inspections as required.
• Identifies potential compliance matters and drives development and implementation of methods for improvement and resolution.
• Responsible to provide GCP compliance guidance and support to BeOne CST and other GCO stakeholders across portfolio of studies in the applicable country / region, ensuring that appropriate GCO study conduct, inspection readiness and overall compliance to applicable regulatory requirements is maintained.
• Ensures appropriate escalation of GCP non‑compliance issue and/or quality events, potential misconduct, and significant deviations to relevant GCO stakeholders.
• Ensures development and implementation of satisfactory CAPA addressing GCP non‑compliance issue / quality event within timelines defined in relevant BeOne SOP.
• Ensures preparation, hosting and management of Site & Sponsor inspections, as applicable.
• Ensures development and implementation of satisfactory CAPA addressing site inspection findings as applicable.
• Ensures the development of GCP inspection readiness programs at study, country, regional and/or global level, as assigned.
• Ensures GCP…