Stability Quality Assurance Manager

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 manages 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 Stability Quality Assurance Manager.

In this role, you will join our dedicated Global Stability Management 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 stakeholders 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.

Essential Requirements

• Educated to Degree or Equivalent experience in a science discipline.
• Experience in Regulatory, QA/QC or pharmaceutical development in a Pharmaceutical or related Industry
• Strong data handling skills and an understanding of the importance of data integrity

To truly thrive in this role, you need to have a well-developed ability to analyse qualitative and quantitative stability information. This in order to draw conclusions and make recommendations, based on clear scientific rationale.

Success factors

As a person you can engage and motivate others. You enjoy working in a team and to develop your network within the business.

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

Are you ready to bring new ideas and fresh thinking to the table? Great! We welcome your application no later than November 24th 2023.

Competitive salary and benefits package on offer.
Opening date: 9th November 2023
Closing date: 8th December 2023

Date Posted

24-Nov-2023

Closing Date

08-Dec-2023

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 authorization and employment eligibility verification requirements.