Stability Quality Assurance Manager, Global Operations

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.



At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business.

The Global Stability Team sits within Operations Quality. The team manages the Global Stability Strategy, Quality Assurance aspects of commercial stability programmes 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 shelf life. The activities of the team support 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.


Accountabilities

As a Stability Quality Assurance Manager, you will join our dedicated Global Stability Management team and we will look to you to demonstrate your technical expertise to support our new and established products.

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. Driving investigations that will involve 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
* An ability to analyse qualitative and quantitative stability 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
* An ability to recognise and react to different perspectives, and negotiate to reach positive outcomes
* Solution based approach



Welcome with your application!

Apply no later than the 19th of May. Interviews will be held during the application period so don't hesitate, apply now!



For internal purposes: this is a career level D role.



AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.