Location Södertälje, Stockholm County, Sweden
Job ID R-227562
Date posted 25/05/2025
Would you like to apply your expertise to impact the quality performance strategy in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be of interest to you!
At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
The Global Stability Management (GSM) Team sits within Global Quality Control & Stability. The team handles and provides stability expertise for technical issues. The group designs and manages an optimised global stability programme to monitor and ensure the quality of our products throughout their shelf life. The team acts globally and support all product licenses in all markets. The group operates in the interface between the operation sites, stability testing sites and the regulatory function. It has prime accountability for proactive and focused support on all aspects of stability management for all global operations sites. The team has a regulatory and technical focus.
We have now an exciting opportunity for you to join this amazing team in a role as Senior Specialist Global Stability.
In this role, you will join our dedicated GSM team, and we will look to you to demonstrate your quality assurance as well as technical expertise to support our new and established products.

WHAT YOU’LL DO

You will be responsible for assuring that a commercial product portfolio is managed in compliance with AstraZeneca’s commercial stability obligations. You will use your expertise to analyse stability information and data to support license management for global products. You will also need skills to influence partners and project team members.
Your role will involve the strategic and technical assessment of supply chain changes, process and packaging changes, and translating findings into the appropriate programmes of stability studies.
The Stability Quality Assurance Manager will be responsible for overall surveillance of data, stability profiles and issues arising from the global commercial stability program. Participate in investigations involving multiple functions from the supply chain of affected products and assure the integrity of stability study reports intended for submission to regulatory agencies. You will also be required to identify issues that may lead to non-compliance with GMP, regulatory requirements and commitments, and advise on areas for improvement across Global Stability Management.

ESSENTIALS FOR THE ROLE

• Bachelor’s degree in science field or a minimum of 5 years’ experience within Quality Assurance, Quality Control, pharmaceutical development or Regulatory, within the pharmaceutical industry
• Strong communication skills (listening, verbal and written in both Swedish and English)
• Well-developed ability to analyse qualitative and quantitative information, to draw conclusions and make recommendations, based on clear scientific rationale
• Strong data handling skills and an understanding of the importance of data integrity
• Experience in Risk and Change Management

DESIRABLES FOR THE ROLE

• Experience in working with biologic products
• Experience from working with products having global supply chains
• Experience in using technical knowledge to make data driven recommendations and take decisions
• Demonstrable awareness of global stability guidelines (ICH and WHO)
• Practical LEAN experience within problem solving, such as Level 0 and PPS
  As a person you can engage and motivate others. You enjoy working in a team and to develop your network within the business.