Associate Director Patient Safety Inspection Excellence at AstraZeneca in Wilmington, Delaware

Job Description:

Are you a seasoned professional in Quality with a passion for Continuous Improvement in Pharmacovigilance? AstraZeneca, a global leader in turning ideas into life-changing medicines, is seeking an Associate Director for Patient Safety Inspection Excellence. We are a company that puts patients first and strives to meet their unmet needs worldwide. If you are swift to action, confident to lead, willing to collaborate, and passionate about Pharmacovigilance and Quality, then this opportunity is for you!



Accountabilities:



As an Associate Director, you will drive a culture of continuous improvement, high performance, flexibility, and quality across the AZ Pharmacovigilance (PV) system. You will lead coordination activities for GVP, GCP, and GMP audits/inspections globally and with local affiliates. You will also support the identification of quality issues and risks, coach CAPA owners and risk owners to develop effective Root Cause Analysis and CAPA/mitigations. Additionally, you will provide training to Global Patient Safety and other functional groups in key areas of expertise.



Essential Skills/Experience:



- A science, pharmacy, or nursing Bachelor's degree, with at least 5 years relevant experience (pharmaceutical pharmacovigilance, regulatory or QA)


- Knowledge of pharmacovigilance requirements


- Experience supporting regulatory inspections


- Knowledge of QMS and continuous improvement methodologies


- Proven ability to work cross-functionally, across cultures and time-zones in a virtual/remote environment


- Leadership skills, including experience of leading project teams



Desirable Skills/Experience:



- Experience in leading preparation, delivery, and response for regulatory inspections


- Experience of working in a global organization in big Pharma


- Thorough scientific knowledge sufficient to understand all aspects of pharmacovigilance issues


- Thorough knowledge of the drug development process


- Ability to influence at a senior level


At AstraZeneca, we follow the science to explore and innovate. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are driven by our desire to understand and reveal new insights. We are free from fear of failure, free to ask the right questions, make bold decisions, and dig deep into the biology of complex disease. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients' lives.


Join us in our Biopharmaceuticals R&D division where curious minds thrive in an inclusive culture. Here all doors are open, and every voice is heard. From working side-by-side with academia to innovating with biotech. we are forever expanding our horizons.



Ready to make a difference? Apply today and join us in our mission to create life-changing medicines!



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.