Section Director, Inspection Excellence job opportunity at AstraZeneca.

Home Jobs In United States Of America Tag: Inspection Excellence Section Director, Inspection Excellence position at AstraZeneca


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AstraZeneca Section Director, Inspection Excellence
Experience: 10-years
Pattern: full-time
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Inspection Excellence

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loacation US - Wilmington - DE, United States Of America
loacation US - Wilmingto..........United States Of America

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: Bachelor's degree in relevant scientific discipline  10+ years of 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 NOW!   Date Posted 27-Jan-2026 Closing Date 02-Feb-2026 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.

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