Senior Director, Regulatory Inspection Excellence
hace 6 días
**Location: Barcelona, Spain (on-site 3 days/week working from the office)**
The Senior Director, Regulatory Inspection Excellence & Readiness is a critical leadership role within Patient Safety, responsible for global organisational preparedness for regulatory, affiliate, and licensing partner inspections and audits. The role directs a global team to implement innovative inspection readiness strategies, and drive continuous improvement considering trends and practices from major inspectorates. Key elements include championing the use of analytics, innovating inspection frameworks and strategy, developing inspection policies and standards, and partnering with QPPV to ensure optimal inspection readiness globally through prediction and trend analysis.
**Typical Accountabilities**
- Develops, maintains, and leads a global inspection readiness strategy, with heightened focus on major regulatory regions.
- Directs team in preparation, conduct, and follow-up of all external inspections and received license partner audits
- Leads end to end PV inspection related activities including but not limited to planning, executive, CAPA response until completion.
- Oversees CAPA management for inspection findings, ensuring robust closure and embedding learnings.
- Sponsors digital and innovative solutions for inspection readiness (e.g., use of advanced technologies, analytics for preparatory activities).
- Delivers integrated, proactive readiness in collaboration across stakeholders.
- Uses inspection intelligence to inform strategic planning and continuous improvement.
- Represents Patient Safety externally with regulators and in professional forums; ensures continual advocacy and knowledge leadership as an innovator in inspection readiness.
- Develops and mentors a high-performing, globally distributed team, championing talent and professional development.
- Provides comprehensive inspection readiness reporting, trend analysis, and recommendations to QPPV/senior leadership.
**Typical People Management Responsibility (direct reports)**
Team leadership responsibility; direct reports globally based, team structure as business evolves.
**Education, Qualifications,**Skills** and Experience**
**Essential**
University degree (or equivalent) in relevant scientific/healthcare discipline
Extensive experience in pharmacovigilance, regulatory compliance, patient safety
Extensive global/regional inspection readiness/audit experience
Demonstrated global QA and compliance leadership
In-depth knowledge of US, EU, China, Japan regulatory environments
Demonstrated innovation in digital inspection solutions
Cross-functional global experience (matrix environment)
Strong US/EU/global inspection/audit track record in life sciences
Excellence in communication, advocacy, and talent development
**Desirable**
PhD or equivalent in scientific discipline
Experience with digital transformation, Lean/process improvement
Business acumen/resource management experience
Familiarity with new/emerging regulatory requirements
Experience with external engagement (industry, regulators)
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