Senior Director Global Development Quality Assurance to support and lead the team in regulatory, compliance, and quality oversight, and establish and maintain collaborative internal & external partnerships globally and locally.
Requirements
- Ensure compliance with global and local health authority regulations, align with BNT QMS and GDQA functions, and establish QA relationships with service providers and collaboration partners.
- Oversee inspection support (training, preparation, facilitation, follow-up, and CAPAs) while providing GCP compliance guidance, audit management, and leveraging global systems and tools.
- Deliver relevant quality metrics, trend observations, and performance indicators while driving risk-based approaches and innovative solutions to address complex challenges.
- Lead cross-functional efforts to embed quality in processes, operating models, and governance frameworks, while implementing change initiatives and driving quality-driven improvements.
- Prepare clear reports, contribute to compliance reporting, and maintain structured stakeholder interactions to ensure quality management frameworks are established and implemented.
- Provide strategic leadership for program and strategy development, collaborate with teams to adjust processes, and act as an ambassador for quality to enable organizational success.
Benefits
- Competitive remuneration package
- Benefits for wellbeing of team members