Director Quality Assurance

Introduction to role

Are you ready to make a difference in the world of healthcare? As the Director of Quality Assurance, you'll play a pivotal role in ensuring that our products meet the highest standards of quality and compliance. Acting as a Qualified Person (QP) on the site license, you'll be responsible for certifying the release of products for sale, ensuring they are supplied in accordance with regulatory requirements and AstraZeneca's company standards. Join us at the Macclesfield Site QA Leadership Team, where you'll provide independent QA leadership and oversight aligned with specific projects, driving continuous improvement and excellence in our operations.

Accountabilities

• Act as a Qualified Person (QP) on the Site Manufacturing License.

• Ensure quality processes and systems within the business area or project align with AZ Quality and Compliance Manual and relevant regulatory requirements.

• Maintain a detailed understanding of medical device and combination products legislation.

• Assure compliant disposition of Finished Product.

• Establish Quality objectives and KPI’s for continuous improvement.

• Implement effective Quality and Compliance Management Review processes.

• Develop professional relationships with external regulatory authorities.

• Lead, develop, and motivate the PET QA team.

• Promote a culture of continuous improvement through lean and six sigma.

• Contribute to efficient design and execution of a complex supply chain.

• Provide strategic and tactical QA support for major projects.

• Contribute to strategy development and execution as part of the Leadership Team.

• Manage QA Operations in line with the approved budget.

• May act as Quality Lead in the Global Supply Team.

• May act as Executive Process Owner (EPO) or Business Process Owner (BPO) for QA processes.

• Represent the function within and outside AstraZeneca.

• Contribute to Site Quality and Compliance strategy development and execution.

Essential Skills/Experience

• eQP Status is essential

• Degree or equivalent experience in a science/technical area such as Pharmacy, Chemistry, or Biology.

• Prior experience in Good Manufacturing/Good Distribution/Good Laboratory practice and compliance management across different Formulation types, with comprehensive knowledge of international GMP requirements/quality systems and Pharmaceutical manufacturing/packing/testing technologies.

• Prior experience in sterile/aseptic formulation is essential to provide expertise across the business area

• High level of technical process understanding across different PET areas.

• Extensive knowledge of quality systems, including change control, deviation management, and New Product Introductions.

• Working knowledge of regulatory interactions and compliance procedures in operations environment.

• Management of complex and changing workload.

• High level of customer focus and ability to maintain quality standards.

• Strong influencing skills across all levels of the organization.

• Knowledge of other areas of the Supply Chain.

• Experience working cross-functionally across the supply chain with groups such as regulatory, Global Quality, Manufacturing, Supply, and Capability.

Desirable Skills/Experience

• International/Multiple Site or Multi-functional experience.

• Managerial/Supervisory experience

• Ability to act as an effective mentor

• Knowledge and experience of Lean and 6 sigma practices in manufacturing operations

This position requires on site presence throughout the week in alignment with the requirements for the position and this will be discussed further at interview.

At AstraZeneca, we are driven by a passion for innovation and excellence. Our commitment to quality is unwavering, as we strive to improve patients' healthcare and their quality of life. With a forward-looking attitude, we empower our teams to take proactive steps in ensuring reliability and excellence in our processes. Here, you'll find an inclusive community where collaboration is key, offering constant opportunities for growth and development. Join us on this exciting journey where your contributions truly matter.

Ready to make an impact? Apply now to join our team!