Director, QMS BPO, Quality Issue Escalation, Risk

General Description

The QMS Business Process Owner is responsible for managing assigned escalated GxP and Quality incidents in an end‑to‑end process on a global level, initiating prevention measures, and maintaining continuous improvement of defined incident management processes within regulated environments.

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and the latest regulatory requirements on a global level.
• Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality‑related issues and incidents in an end‑to‑end process, including those resulting from deviations, regulatory and/or GxP non‑conformances or other quality events.

• Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.

• Drive and support comprehensive root cause investigations.
• Drive and oversee the development of corrective and preventive action plans and lessons learned related to escalated GxP and Quality incidents.
• Drive initiation and execution of market actions if required.

• Ensure that escalation and notification to management activities and documentation meet the relevant regulatory agency and other industry requirements (FDA, EMA, local regulations, ISO, WHO).
• Prepare for and support inspections and audits.

• Develop and deliver training on incident management procedures.
• Share lessons learned from managed GxP/Quality incidents and promote a culture of quality and accountability across the organization.

• Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
• Master’s degree and 10+ years of direct experience preferred.

• 6 years of managerial experience directly managing people and/or leading teams, projects, programs, or resource allocation.

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Ability to learn specialized platforms (Veeva, Power BI, Calyx, SAP, etc.).

• Experience with regulatory interactions including notification and communication with health authorities on a global level for sensitive compliance topics.

Up to 20% travel.

CHF -  CHF.

BeOne is 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.