FIND INTERNSHIPS

Senior Director, Patient Safety Inspection Excellence

Posted on Oct. 29, 2025 by AstraZeneca

  • Full Time

Senior Director, Patient Safety Inspection Excellence

Location:

Barcelona, Spain (on-site 3 days/week working from the office).

Gothenburg, Sweden (on-site 3 days/week working from the office).

The Senior Director, Patient Safety Inspection Excellence 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)


Advertised until:
Nov. 28, 2025


Are you Qualified for this Role?


Click Here to Tailor Your Resume to Match this Job


Share with Friends!

Similar Internships


No similar Intern Jobs at the Moment!