Associate Director, Device & Digital Safety
Location: Cambridgeshire, Cheshire East
Job Type: Full time
Do you have expertise in, and passion for, Patient Safety? Would you like to apply your expertise to impact the Device & Digital team in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
The position is a member of the Device & Digital Safety CoE, part of Global Patient Safety and sitting in the Chief Medical office. The responsibilities include management of invitro diagnostic processes and partnerships. The role champions the implementation, communication, compliance, performance and inspection readiness within Patient Safety. In addition to this, the unique responsibility of providing Patient Safety's input enterprise wide processes and projects related to devices, digital and diagnostics.
Come and join our AZ team where you will play a pivotal role in this exciting period of development.
What you’ll do
Responsible for the management of Patient Safety procedures related to invitro diagnostic including process creation, implementation, communication, performance and inspection readiness.
Supporting the wider process area of device & digital safety
Ensure that internal processes are fit for purpose and maximise the efficiency of the outsourced delivery, working with relevant partners to improve processes
For the processes assigned, responsible for ensuring compliance with safety and performance global regulations and health authority requirements
Deliver projects to agreed targets and provide expert operational / strategic input and guidance (regulatory, pharmacovigilance and patient safety) to cross-functional teams
Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes, deliveries and partnerships
Manage relationships/partnerships/alliances external to the AZ CMO function that are important to delivering AstraZeneca's Patient Safety & Pharmacovigilance license to operate responsibilities.
Contribute to the overall management and oversight of the Patient Safety Quality System
Establish relationships with collaborators and customers to support pharmacovigilance and regulatory activities and responsibilities, including successful partnerships
Participate and /or support activities for GVP, GCP, GRP and GMP audits/inspections
Partner with License Agreement & Contracts where medical devices, device constituents, digital health or diagnostics are involved
Engage and influence internal and external key partners to drive the strategy, development and continuous improvement of processes, technology and services within the diagnostic area that they lead.
Partner with Patient Safety Systems counterparts to ensure a coordinated approach to processes and systems.
Support AZ compliance with invitro diagnostic health regulatory and legal requirements, including implementation of new regulatory & legal requirements
Essential for the role
University degree or equivalent qualification in relevant scientific field, with relevant experience (pharmaceutical, regulatory, safety, pharmacovigilance, digital health).
At least one year's professional experience in patient safety, regulatory affairs or in quality management systems relating to invitro diagnostics
Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals
Making a difference every day by delivering life-changing medicines to millions of people globally, our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a culture that inspires innovation and collaboration. If this sounds like the place for you - don't hesitate to apply and join us to become part of a Great Place to Work!
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 already envisioning yourself joining our team? Good, because we can’t wait to hear from you. Please apply no later than 5th February, 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.