UK (Macclesfield)

Salary & Benefits Competitive

Bold Disruptors. Push the boundaries of science Daringly break new ground

Work in a ground-breaking environment, where scientific innovations and an ambitious spirit are the norm. And in return… we’re looking for curious minds, comfortable taking sensible risks and learning from failures!

In Operations, we have a big ambition – to deliver more medicines to patients, quicker and more affordably! Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

This position is placed within the Global Stability Management group. The role holder is a recognised authority across Operations on stability related matters, and ensures compliance with AstraZeneca’s commercial stability obligations, through having the oversight of regulations, product lifecycle and strategies, and stability quality profile knowledge.

The role demands thorough understanding of pharmaceutical stability testing and a full overview of Operations.

What you’ll do

• Build an expertise in all aspects of stability management and maintain awareness of changing regulatory requirements and provide an ‘internal consultancy’ role to AZ
• Be the ex[ert and coach for the members of GSM and ensure appropriate evaluation is carried out by the team members in the role of expert
• Build effective networks across the global Operations organisation, Pharmaceutical Development and Regulatory Affairs
• Deliver SHE and cGMP compliance across GSM ensuring that all work is carried out with regard to AstraZeneca and external regulatory standards
• Ensure the appropriate stability direction of work on all APIs, established products and major brands
• Operate using risk management principles
• Collaborate effectively with partners in Operations and across R&D
• Represent the stability function in global cross-product and strategic change projects
• Interpret changing regulatory requirements and assess the impact on the AZ processes and standards, including cross functional discussions and development of AZ stability related positions
• Continually challenge ways of working to ensure the stability plans are optimized and effective
• Maintain overall surveillance of data/issues arising from the international commercial stability program and support investigations that may result in non-compliance regarding GMP and/or Regulatory requirements and commitments, or result in product recalls
• Support the GSM QA systems with controlling and guiding documents such as SOPs and international procedures
• Support external and internal regulatory inspections for all aspects of stability management

Essential requirements

• BSc or PhD level in an appropriate scientific field
• In depth understanding in the subject areas in analytical science, formulation and global supply chain
• Thorough knowledge of cGMP requirements and applicability to manufacturing, distribution, and analytical testing
• Thorough understanding of SHE and cGMP
• Experience in Operations and/or R&D
• High level of understanding of change management

Desirable Skills

• Experience in or exposure to multiple fields in CMC and related functions (eg Product Development, Operations, Global Supply, Marketing Companies)
• Have previous experience and training in Lean and six sigma, problem solving tools
• Have experience in data analysis, interpretation, scale up, manufacturing engineering and digital twins/modelling
• Have strong leadership skills and behaviours with demonstration of being able to work across different functions
• Evidence of excellent communication skills and build excellent relationships with customers
• Excellent teamworking and networking skills and Capable of making effective decisions

Be empowered to be innovative and creative where difference is valued

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel 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. Always committed to lifelong learning, growth and development.

So, what’s next...

Complete your application before the below closing date.

This role is open from 4th August and we encourage your application no later than 17th August 2022.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Date Posted

Closing Date

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.