Software Quality Assurance Director jobs in Delaware

Are you ready to pioneer a new' Quality way? Develop your expertise by being both challenged and supported to apply a modern' Quality mindset. It means taking accountability and making brave decisions. Whether that's reimagining the best way to respond to procedures and regulations, or pushing back when there's disagreement. We partner and problem-solve with product and process experts to ensure we perform with excellence across the Quality network. 

Introduction to role:

Are you a quality professional with expert subject knowledge and experience of Learning & Development and Operations GxP Training? We are looking for someone like you to control, monitor and develop systems, processes and procedures that are compliant, scalable and efficient to enhance the approach to quality and quality management system globally. You will be responsible for liaising with the business in analysing employee training needs to establish requirements for new program development. This role reports to the Head of Operations Quality Learning & Development and GxP Learning.  

Accountabilities: 

As a Director Operations Quality Learning Business Process Owner, you will help create an environment of change, encouraging others to suggest areas for improvement in existing Learning & Development tools, methods or processes to deliver elite learning and development activities. You will design & lead the global standards and procedures, ensure all global procedures and processes meet regulatory requirements and reflect cGMP, and be accountable for the performance of the process globally. You will also provide subject matter authority advice & coaching, training materials, certification requirements and job aids/manuals.  

Essential Skills/Experience: 

• Bachelor’s degree and/or substantial meaningful experience in pharmaceutical quality or manufacturing 

• Experience in multiple areas of Quality within a pharmaceutical environment 

• SME knowledge/experience of GxP Training Requirements and Regulations 

• SME experience with LMS systems, training management, development and delivery 

• Strong technical writing skills required 

• Experience in working cross-functionally / cross culturally across the supply chain 

• Excellent written and oral communication skills and ability to build relations across the network and with cross functional customers 

• Sound knowledge of PQS requirements 

• With experience of working in global teams you will have the ability to influence and define strategy for global way of working 

• Strong risk-based decision-making skills 

• Independence and ability to work with minimal direction 

Desirable Skills/Experience: 

• Experience in leading transformational change programs across global Quality Control 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 

• Strong business insight and ability to assess trends, complex data sets and generate robust business cases and impact analysis. 

• Training and certification in Lean, Six Sigma and similar recognized industry continuous improvement programs 

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. 

Why AstraZeneca? 

At AstraZeneca, our work is important and valued. We have an unrivalled forward-looking mindset, there's no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. discovery, development and commercialisation. We are a team of ambitious people, who want to go far and we're all here to achieve. It's what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes.  

Apply now and join us in our mission to improve the lives of patients worldwide!