at AstraZeneca Pharmaceuticals LP (AZPLP) in Wilmington, Delaware, United States
Job Description
Job Title: Senior Director Global Quality Risk ManagementIntroduction to Role:
Are you a quality professional with a deep understanding of Quality Risk Management and experience in Quality Management Systems? We are seeking a dynamic individual to provide strategic direction and implement a Proactive Quality Risk Program across AstraZeneca. This role will control, monitor, and develop systems, processes, and procedures that are compliant, scalable, efficient to enhance the proactive approach to quality and quality management system globally.
Accountabilities:
As the Global Quality Business Process Owner (BPO), you will design and own global standards and procedures, ensure all global procedures and processes meet regulatory requirements, and reflect cGMP. You will be accountable for the performance of the process globally, engage & lead a global process network, provide subject matter expert advice & coaching, and much more. This role is specifically responsible for acting as a BPO for Quality Risk Management, defining and providing quality requirements for risk management globally, driving and implementing the Proactive QRM strategy, developing Quality Risk capability, culture and maturity across sites and regions, and managing the Quality Risk Register.
Essential Skills/Experience:
- Bachelor's degree 15+ years of substantial relevant experience in pharmaceutical quality or manufacturing
- Experience in multiple areas of Quality within a pharmaceutical environment
- Subject matter expertise of Quality Risk Management including successful implementation of a Risk Management Program
- Experience in working cross-functionally / cross culturally across the supply chain
- Excellent communication skills and ability to build relations across the network and with cross functional customers
- Ability to influence and define global way of working
- Independence and ability to work with minimal supervision
- Experience in working in global teams
- Manage through influence
- Experience in leading transformational change programs across global Quality and Operations networks
- Experience with DAI or similar decision-making process and models
- Experience with Business Process Management
- Project management experience in PM, lead and governance roles
- Experience with global IT GMP Quality system delivery and lifecycle management
- Training and certification in Lean, Six Sigma or similar recognized industry continuous improvement programs
- Strong business acumen and ability to assess trends, complex data sets and generate robust business cases and impact analysis.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we champion a mindset of excellence. We believe that good can always be better. We search for opportunities to add value, harnessing science and evidence to foresee risk. We continuously innovate to find new and better ways to ensure we are improving outcomes for patients. Our work in Quality is important and valued. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We take Quality seriously. We draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first.
Are you ready to step into a role that lets you do important work that is valued? Apply today!
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.
