AstraZeneca

Pharmaceutical

ComplianceExcellenceDirector

€115–175k ~AI est. Spain FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“Compliance Excellence Director at AstraZeneca. Skills: Pharmacovigilance, Regulatory compliance, Quality management, Risk mitigation. Lead implementation of operating model. Lead continuous improvement of operating model”

What You'll Achieve.

Reduce risk in safety system; Strengthen inspection readiness; Provide clarity for leaders; Provide evidence for leaders; Faster delivery of therapies; Safer delivery of therapies; Raise quality; Raise efficiency

Industry & Context.

Pharmaceutical
Problems you'll solve

Risk mitigation; Process improvement; Remediation

What They're Looking For.

Must Have

University degree or equivalent qualification, Extensive experience in pharmacovigilance, Extensive experience in regulatory compliance, Experience in pharmaceutical environment, Experience in clinical environment, Experience in regulatory environment, Experience in pharmacovigilance environment, Comprehensive knowledge of global regulatory requirements, Comprehensive knowledge of pharmacovigilance requirements, Ability to manage multiple stakeholders, Experience influencing senior-level stakeholders, Excellent written communication skills, Excellent verbal communication skills, Negotiation skills, Collaboration skills, Conflict management skills, Interpersonal skills, Audits experience, Inspections experience, Quality Assurance experience

Nice to Have

Broad understanding of technical requirements within PV, Broad understanding of regulatory technical requirements, Ability to balance technical requirements with industry standards, Extensive project management skills, Experience leading teams, Experience in line management, Knowledge of new regulatory expectations, Knowledge of developing regulatory expectations, Knowledge of new pharmacovigilance expectations, Knowledge of developing pharmacovigilance expectations, Process improvement experience, Lean methodology experience, Financial awareness

What You'll Do.

Lead implementation of operating model

Lead continuous improvement of operating model

Ensure consistency of operating model

Ensure scalability of operating model

Monitor completeness of PV processes

Monitor effectiveness of PV processes

Monitor compliance of PV processes

Identify trends in PV processes

Escalate significant risks

Prepare governance forums

Steer governance forums

Deliver high-quality materials

Drive timely follow-up to decisions

Drive timely follow-up to actions

Oversee monitoring of performance

Oversee tracking of performance

Oversee analysis of performance

Convert data into insights

Develop targeted improvement actions

Ensure corrective measures are in place

Ensure preventive measures are in place

Ensure oversight measures are in place

Mitigate critical-to-quality risks

Drive adoption of innovative approaches

Drive adoption of enabling technologies

Improve user experience

Partner with inspection experts

Translate learnings into preventive measures

Translate learnings into effective remediation

Build inspection-readiness into ways of working

Collaborate to interpret legislation

Collaborate to embed legislation into processes

Collaborate to embed legislation into standards

Collaborate to embed legislation into training

Promote quality culture

Promote compliance culture

Provide clear expectations

Align diverse perspectives

Engage with internal leaders

Engage with external partners

Ensure alignment with partners

Share best practices with partners

Maintain outward-looking stance

How You'll Work.

Team & Collaboration

Cross-functional stakeholders; Cross-geographies teams; Internal leaders; External partners

Communication Scope

Written communication; Verbal communication; Negotiation; Collaboration; Conflict management

Process & Methodology

Project management, Leading teams

Full Job Description

**** **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

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