ESM Quality Director, Technology Area - Global Operations

Are you ready to lead a global team of Quality Assurance professionals and make a significant impact on the delivery of life-changing medicines?

As the External Supply and Manufacturing (ESM) Quality Director for the Formulation, Fill and Packing (F&P) Technology Area, you will be responsible for the leadership of the Quality Assurance/Compliance organization, partnering with AstraZeneca's ESM organizationfor FP. You will ensure compliance and quality management of all global external suppliers associated with this technology area. Join us and be part of a team that shapes the future of quality in pharmaceuticals and biopharmaceuticals!

Your role

We are seeking a dynamic individual to lead our Technology Area Quality function. In this role, you will provide leadership to our Quality Assurance Professionals who support External Operating Teams in delivering high-quality products to patients in a cost-effective manner. You will be responsible for developing a skilled Quality Assurance team to manage supplier quality for existing, new commercial, and exiting external suppliers within the technology area. Building strong Quality relationships with all ESM customers, AZ manufacturing sites, and marketing companies will be a key aspect of this role.

As a leader in this area, you will contribute to strategy development and lead implementation to improve the global external portfolio performance over time. You will be responsible for managing issue support within the Technology area and coaching and supporting team members in completing their accountabilities.

Interacting with Regulatory Inspectors during inspections within AstraZeneca and at suppliers, as well as representing AstraZeneca at Quality, Business Review meetings, and senior leader meetings, will be part of your responsibilities.

Finally, understanding legal and regulatory requirements to provide appropriate resources for maintaining and improving the Quality system will be an important aspect of this role. If you are a motivated individual with a strong background in pharma/biopharma manufacturing Quality and leadership, we encourage you to apply for this exciting opportunity.

Essentials for the role

• Bachelor’s degree in science or technical area

• Experience in regulatory compliance or quality assurance

• Knowledge of international requirements for current Good Manufacturing Practice

• Experience working on critical acute problems in multifunctional, international senior-level teams

• Good understanding of broader global quality management systems and philosophies

• Direct experience in regulatory inspections and other face-to-face contact with Regulatory Authorities

• Awareness of pharmaceutical development and regulatory processes

• Strong familiarity with AstraZeneca processes and products, culture, and policies

• Line management experience

• Experience working with global external suppliers, contract manufacturers.

• Understanding/awareness of Business, financial, and supply chain ways of working

• SHE, GMP, and regulatory management knowledge

• Lean manufacturing principles understanding, experience, and practitioner

Desirable for the role

• Advanced Degree in science or technical area

• Familiarity with Good Laboratory and Good Clinical Practices

• Good external industry network

• Experience in a technology area manufacturing environment

• Understanding of pharmaceutical drug manufacturing end-to-end

• Experience in both small and large molecule manufacturing 

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 are at the forefront of innovation, constantly trialing new models and technologies to improve reliability and excellence in our processes. Here you'll feel empowered to step up, follow the science, and make decisions that put patients first. Our inclusive community ensures every voice is heard, fostering a sense of camaraderie as we work together to deliver life-changing medicines.

Ready to make a difference? Apply now to join our team!

Welcome with your application, no later than Nov 17th, 2024.