Head of Global Stability
Cambridge, United Kingdom
4d ago

Head of Global Stability Quality Control

Locations : UK (Macclesfield), Sweden (Sodertalje)

At AstraZeneca when we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big.

Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential.

Corporate Quality & Strategy own, improve and sustain the global Pharmaceutical Quality System (PQS) and processes to enable efficient delivery of safe and effective medicines to patients, meet global regulatory expectations and enable a strong quality culture.

We do this by prioritizing and managing the portfolio of Operations Quality global initiatives that enable advances in compliance, efficiency, technology adoption and performance.

Our diverse and experienced team of experts in Quality, Lean, project / programme management and communications work with key stakeholders across the business to deliver new ways of working, building in quality as a proactive approach that advances the business beyond maintaining our compliance Licence to Operate.

Our team provides global leadership and have accountability for :

  • Pharmaceutical Quality Management System
  • Issues Management Team
  • Global Quality Control
  • Global Stability
  • Quality Business Performance
  • Quality Digital Strategy and enterprise systems
  • The role Head of Global Stability

    This is a key leadership role within Corporate Quality & Strategy leading a Stability global technical services that is responsible for proactive technical support on all aspects of Stability non engagement for all Global Operations manufacturing sites.

    The role has responsibility for the AstraZeneca Pharmaceutical GMP Commercial Stability programme on a global basis this will ensure the management of stability requirements, execution, analysis and reporting in compliance with current Good Manufacturing & Distribution Practices in a way that supports and advances long and short term business objectives.

    This is an exciting role within Corporate Quality and Strategy which gives you the opportunity to drive transformation and new ways of working across Global Stability.

    Key Accountabilities

    In this role, you will take ownership of the Operations global stability strategy and framework based on benchmarking and monitoring of regulatory guidelines, regulatory and industry trends and current best practices.

    You will provide leadership to the Global Stability Management organisation and lead Stability Governance across AstraZeneca as well design the commercial stability programme ensuring it meets regulatory requirements and ensures safety and efficacy of the products through their product shelf life.

    Define the policies, standards and processes for the execution of the Stability programme and develop and maintain predictive models to forecast stability testing demand and resource requirements.

    Proactively identify and address trends or signals related to stability results that could cause an adverse impact to supply or regulatory action.

    You will develop and mature a multi skilled team comprising of experts in stability, stability co-ordination, program management, analysis of data and process knowledge.

    Essential requirements :

  • PHD or Bachelor’s degree equivalent experience will be considered
  • Strong relevant experience in pharmaceutical quality, manufacturing or regulatory roles
  • Strong leader, able to set direction and instil commitment to a quality culture
  • Extensive experience of leading and managing teams of people, large scale programs and financial budget management
  • Experience of working in cross functional and global teams
  • Able to evidence experience of applying robust judgement in high profile and high pressure situations
  • Thorough knowledge of cGMP requirements related to stability testing, analytical testing, method performance and statistical analysis of analytical data
  • Understanding of pharmaceutical manufacturing, distribution, analytical development processes and the interdependencies between these disciplines
  • Demonstrable track record of delivering results by driving performance, collaborating and building trust across boundaries and building strong networks
  • Strategic thinking, influencing and communication skills able to explain complex ideas in clear and compelling ways to multiple stakeholder groups
  • Knowledge of Lean leadership approaches and ability to simplify complexity
  • Apply
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