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. 

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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) 

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.