Section Director, Inspection Excellence

AstraZeneca • Gaithersburg, MD

98d

About The Position

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.

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

Responsibilities

• 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
• 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
• 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
• Contribute to overall QPPV&PVE team strategy and goals as a member of QPPV&PVE LT
• 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees