Compliance Excellence Director

AstraZeneca
AstraZeneca
Barcelona, SpainOn-siteCompetitiveAdded 2 days ago

Original Advert

Introduction to role:

Are you ready to elevate global pharmacovigilance quality to protect patients and accelerate transformative cancer medicines? This role puts you at the center of patient safety, where rigorous compliance enables bold science to move with confidence and speed.

As Director, Compliance Excellence, you will shape a consistent, insight-led operating model for pharmacovigilance quality and compliance across multiple countries. Your work will reduce risk in our safety system, strengthen inspection readiness, and provide the clarity and evidence leaders need to make decisions that benefit patients. Do you translate complex regulations into clear, scalable ways of working that teams can adopt and sustain?

You will collaborate across functions and geographies, guiding teams through evolving regulatory expectations while embedding practical governance, robust metrics, and continuous improvement. The impact is tangible: faster, safer delivery of therapies to people who need them most.

Accountabilities:

- Quality and Compliance Operating Model: Lead the implementation and continuous improvement of an integrated operating model that fulfils applicable regulatory requirements across the pharmacovigilance system, ensuring consistency and scalability.

- PV Process Oversight: Monitor the completeness, effectiveness, and compliance of assigned pharmacovigilance processes, proactively identifying trends and escalating significant risks to safeguard the PV system.

- Compliance Governance: Prepare and steer effective governance forums, including monthly and quarterly compliance meetings and councils; deliver high-quality materials and drive timely follow-up to decisions and actions.

- Performance Insights: Oversee the monitoring, tracking, and analysis of performance using established KPIs and compliance frameworks; convert data into insights and targeted improvement actions that raise quality and efficiency.

- Risk Control and Remediation: Ensure appropriate corrective, preventive, and oversight measures are in place to mitigate critical-to-quality risks, with clear ownership, timelines, and measurable outcomes.

- Innovation and Enablement: Drive the adoption of innovative approaches and enabling technologies that simplify processes, strengthen controls, and improve user experience without compromising compliance.

- Inspection and Audit Integration: Partner with inspection experts to translate learnings into preventive measures and effective remediation for significant findings; build lasting inspection-readiness into ways of working.

- Regulatory Change Integration: Collaborate with cross-functional stakeholders to interpret and embed evolving pharmacovigilance legislation into processes, standards, and training at pace.

- Culture and Leadership: Promote a strong quality and compliance culture by providing leadership, guidance, and clear expectations across teams; influence without authority to align diverse perspectives around practical solutions.

- External and Internal Partnerships: Engage with internal leaders and, where relevant, external partners and organizations to ensure alignment, share best practices, and maintain an outward-looking stance on regulatory and industry trends.

Essential Skills/Experience:

- University degree or equivalent qualification in relevant scientific discipline

- Extensive experience in pharmacovigilance and regulatory compliance within a pharmaceutical, clinical, regulatory or pharmacovigilance environment

- Comprehensive knowledge and understanding of global regulatory and pharmacovigilance requirements

- Ability to manage multiple stakeholders

- Experience in working with and influencing senior-level stakeholders

- Demonstrated excellent written and verbal communication skills, negotiation, collaboration, conflict management and interpersonal skills

- Audits and Inspections and Quality Assurance experience

- Key capabilities:

- Understanding of governance processes

- Collaboration/co-ordination

- Ability to influence without authority

- Open to multiple perspectives

- Balanced perspective - Solution focused

Desirable Skills/Experience:

- A broad understanding of the technical requirements within PV and regulatory and an ability to balance this with industry standards to achieve business goals

- Extensive knowledge in project management skills, specifically leading teams

- Experience in line management on a regional/global basis

- Knowledge of new and developing regulatory and pharmacovigilance expectations

- Preferred capabilities: - Process improvement (e.g., Lean methodology)

- Financial awareness

Why AstraZeneca:

Here you will join teams united by a bold ambition to change the course of cancer and the lives it touches. We pair cutting-edge science with the latest technology and robust investment, moving at pace from discovery through development with patient outcomes as our north star. You will find pragmatic collaborators-regulatory experts, clinicians, data scientists, and safety specialists-solving tough problems together, often in the same room, to unlock smarter, safer decisions. We value kindness alongside ambition, empower leaders at every level, and give you the scope to turn insight into action that directly advances our pipeline and protects patients worldwide. Call to Action: If you are ready to lead compliance that safeguards patients and accelerates breakthrough medicines, step forward and shape what excellence looks like today!

Date Posted

04-jun-2026

Closing Date

19-jun-2026

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.

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