Director Quality Assurance

Are you a seasoned Quality Assurance professional with a passion for patient well-being and a drive for operational excellence? AstraZeneca is seeking a highly skilled Director of Quality Assurance to join their Macclesfield Site QA Leadership Team. This is a critical role where you will not only uphold the highest standards of quality and compliance but also act as a Qualified Person (QP) on the site license, directly impacting product release and patient safety.

This opportunity offers a unique chance to contribute to a leading global biopharmaceutical company dedicated to innovation and improving lives. If you are looking for a leadership role with significant impact and the chance to shape quality strategies within a dynamic environment, read on to discover why this position might be the perfect next step in your career journey.

Key Advantages of This Opportunity:

• Direct Impact on Patient Health: As a Qualified Person (QP), you will hold the ultimate responsibility for certifying product release, ensuring that every medicine meets stringent quality and regulatory requirements before reaching patients.
• Strategic Leadership Role: You'll be a key member of the Site QA Leadership Team, providing independent QA leadership and oversight for specific projects, contributing to the overall site strategy, and driving continuous improvement initiatives.
• Deep Dive into Complex Operations: This role demands a thorough understanding of medical device and combination products legislation, alongside expertise in pharmaceutical manufacturing, packing, and testing technologies, particularly in sterile/aseptic formulation.
• Fostering a Culture of Excellence: You will lead and develop the PET QA team, promoting a culture of continuous improvement through lean and Six Sigma methodologies, and championing quality across the organization.
• Cross-Functional Collaboration: Engage with a wide range of internal and external stakeholders, including regulatory authorities, global quality teams, manufacturing, supply chain, and more, fostering strong professional relationships.
• Career Growth and Development: AstraZeneca is committed to employee growth, offering a collaborative and inclusive environment with constant opportunities for development. This role provides exposure to global supply chain complexities and senior leadership discussions.

Key Considerations for Candidates:

• Essential QP Status: Candidates must possess eQP status, a fundamental requirement for this position.
• Science and Technical Foundation: A degree or equivalent experience in a science or technical field such as Pharmacy, Chemistry, or Biology is essential.
• Extensive GMP & Quality Systems Knowledge: Prior experience in GMP, GDP, GLP, and compliance management across various formulation types, with comprehensive knowledge of international GMP requirements and quality systems, is paramount.
• Sterile/Aseptic Formulation Expertise: Specific prior experience in sterile/aseptic formulation is crucial to provide vital expertise across the business area.
• Adaptability and Resilience: The ability to manage complex and changing workloads, coupled with a high level of customer focus and the ability to maintain quality standards under pressure, is vital.
• Strong Influencing Skills: Success in this role will depend on your ability to influence effectively across all levels of the organization.
• On-Site Presence: This position requires full-time on-site presence, ensuring active engagement and oversight within the Macclesfield facility.

This is a significant leadership opportunity for a dedicated Quality Assurance professional to make a tangible difference in the pharmaceutical industry. If you are driven by quality, possess the required expertise, and are eager to contribute to a world-class organization, we encourage you to explore this exciting role further.