At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working. 

Currently we are looking for Section Director, Inspection Excellence. The Section Director, Inspection Excellence serves as a key leadership role within the Inspection Excellence team, reporting to the QPPV & PV Excellence team in Global Patient Safety. This position is responsible for leading a team of direct reports and collaborating with the Director Inspection Excellence Lead and Senior Director CIE to execute Inspection Excellence strategy and objectives. The role encompasses ensuring inspection readiness across Patient Safety operations, coordinating regulatory inspections and audits, and developing quality improvement initiatives.   .

Responsibilities:

Inspection Readiness and Coordination 

Maintain continuous inspection readiness across all Patient Safety functions 

Lead coordination of GVP, GCP, and GMP inspections and audits 

Ensure appropriate pharmacovigilance expert input throughout inspection processes 

Coach team members to develop expertise in inspection coordination 

Quality Management and Compliance 

Develop high-quality pharmacovigilance Quality Issues and Risk assessments with corresponding CAPA 

Utilize root cause analysis methodologies to support quality improvement initiatives 

Manage timely delivery of effective pharmacovigilance CAPA and risk mitigation strategies 

Report pharmacovigilance quality status to business leadership and senior management 

Team Leadership and Management 

Provide strategic leadership and direction for the Inspection Excellence team 

Manage team performance and professional development to achieve strategic goals 

Collaborate with the Inspection Excellence Leadership Team to define organizational strategies and objectives 

Member of QPPV&PVE LT contributing to overall QPPV&PVE team strategy and goals 

Strategic Operations and Innovation 

Identify opportunities to implement AI and automation technologies to enhance efficiency and quality 

Establish systematic processes for gathering, consolidating, and communicating regulatory authority and industry intelligence 

Drive proactive continuous improvement initiatives to ensure regulatory compliance and operational excellence 

Manage projects according to established targets while providing expert pharmacovigilance guidance 

Stakeholder Engagement and Collaboration 

Maintain effective relationships with QA functions within R&D, EU Qualified Person for Pharmacovigilance, Global Markets, Clinical functions, and Operations 

Engage and influence internal and external stakeholders to advance strategic objectives 

Ensure customer requirements are understood, evaluated, prioritized, and addressed appropriately 

Participate in governance of alliance and partnership models 

Requirements:

University degree in relevant scientific discipline 

Demonstrated experience in pharmacovigilance and regulatory compliance within pharmaceutical, clinical, regulatory, or pharmacovigilance environments 

Comprehensive knowledge of global pharmacovigilance requirements 

Experience with regulatory inspection activities 

Proven ability to manage multiple stakeholders effectively 

Experience applying strategic direction to teams and projects within cross-functional or global environments 

Extensive project management experience with team leadership responsibilities 

Demonstrated ability to utilise AI and automation technologies to enhance efficiency and quality 

Regional or global line management experience 

Excellent written and verbal communication and presentation skills 

Strong attention to detail, time management, and organizational abilities 

Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY! 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.