Stability Programme Manager
Are you prepared to take on a crucial role that ensures AstraZeneca meets its commercial stability obligations? As a Stability Programme Manager, you'll be at the forefront of developing, implementing, and maintaining our Global Commercial Stability Programme. This position requires a deep understanding of pharmaceutical stability testing and a comprehensive grasp of Operations activities, contributing significantly to our business objectives. You'll engage with collaborators and project team members, providing direct advice and influence.
Key Responsibilities
For assigned products, demonstrating your expert stability programme knowledge and product overview, you will:
Ensure the global stability programme adheres to regulatory requirements and is optimized for effectiveness and sustainability.
Develop and maintain Stability Master Plans and associated data, including specifications, product documents, protocols, and packaging equivalences.
Collaborate with Stability QC Centres, regulatory functions, and key partners to create and manage stability studies and provide submission-ready data.
Identify and address issues leading to stability-related non-compliance, while engaging in Global Stability Management Business Process Management and driving continuous improvement.
Lead quality records using a risk-based approach, mentor team members, and conduct activities in line with AstraZeneca's Values, Code of Ethics, and relevant policies.
Essential Skills and Experience
Knowledge of synthetic/biologics processes or QC analytical methods and specifications.
Strong communication skills (listening, verbal, and written in English).
Excellent teamwork capabilities.
Meticulous and thorough in information handling.
Ability to understand diverse perspectives and influence positive outcomes.
Proactive and able to deliver under pressure.
Familiarity with lean principles and methodology.
Desirable Skills and Experience
Experience with GQCLIMS.
Knowledge of Cell Therapy, Antibody Drug Conjugates, Virus-Like Particles, Monoclonal Antibodies, or Radiopharmaceuticals.
Experience in implementing Digital/AI tools.
Why AstraZeneca?
At AstraZeneca, we believe in the power of unexpected collaborations to inspire life-changing medicines. Our in-person work environment fosters connection, quick-paced work, and the challenging of perceptions. While we expect office presence three days a week, we also value and respect individual flexibility.
Innovate with Us
Join us at AstraZeneca, where a modern Quality mentality is at the heart of what we do. You'll be empowered to take accountability and make courageous decisions, whether reimagining regulatory responses or pushing boundaries. Collaborate with product and process experts to ensure excellence across our Quality network.
Ready to make a difference? Apply now to join our team and embark on a journey of growth and impact!
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 authorisation and employment eligibility verification requirements.
