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Cambridge, England, United Kingdom · On-site
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Cambridge, England, United Kingdom • Hybrid
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Lead and deliver complex risk-based audits and assurance programs across GxP, diagnostics, and medical device environments. Act as a strategic advisor to senior leadership to ensure compliance and support innovation in digital health and diagnostics.
Requires a degree and significant experience in QA and auditing within the pharmaceutical industry, specifically with IVDs and global regulatory frameworks. Must demonstrate a proven ability to lead quality due diligence and manage CAPA plans in complex regulated environments.
Director, Quality Assurance (Diagnostics & Devices)
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.
As Director of Quality Assurance, you will be a strategic leader and trusted advisor in diagnostics and medical devices, shaping risk-based assurance across R&D. You will lead complex audits and inspections while guiding and enabling stakeholders to deliver compliant, risk-based outcomes in a rapidly evolving regulatory environment. Through strong collaboration and senior level influence, you will cultivate a culture of quality and support innovation in diagnostics, devices, and digital health.
Plan, lead and deliver complex audits across GxP, diagnostics, and medical device environments
Execute and continuously improve a risk-based assurance programme, ensuring effective coverage across assigned areas
Assess, approve, and coordinate CAPA plans, ensuring timely and effective resolution of compliance risks
Deliver high-quality audit reporting, clearly articulating risk, impact, and recommended actions
Monitor compliance intelligence and emerging trends to inform audit focus and priorities
Lead and support regulatory inspections, including preparation, execution, and follow-up
Represent QA in governance forums, contributing to enterprise-level quality strategy and decision-making
Shape and contribute to the strategic direction of QA assurance in diagnostics and medical devices
Act as a trusted advisor to senior leaders, providing pragmatic guidance on quality, compliance, and regulatory expectations
Lead and support due-diligence activities, providing QA expertise to inform business decisions, partnerships, and acquisitions
Provide oversight and guidance on quality issue management within diagnostics and device areas, ensuring robust, risk-based resolution
Partner with stakeholders to identify, assess, and mitigate risk, enabling confident, compliant decision-making
Build strong, collaborative relationships across R&D, fostering a culture of quality, integrity, and continuous improvement
Provide thought leadership on emerging regulatory requirements (e.g. IVDs, SaMD, digital health)
Coach and mentor QA colleagues, strengthening capability and consistency across the function
A degree (or equivalent experience) and bring significant experience in Quality Assurance, auditing, or compliance within pharmaceuticals,
Experience with in-vitro diagnostics (IVDs), including companion diagnostics, in a regulated pharmaceutical environment, and with a practical understanding of the regulatory and quality standards applied to diagnostic development partners.
Experience working across multiple regions and navigating global regulatory expectations.
Experience leading or supporting quality due diligence for partnerships, licensing, acquisitions, or other strategic business activities, with the ability to identify quality and compliance risks.
Demonstrated ability to identify, assess, and mitigate quality and compliance risks, supporting robust and confident business decision-making.
Hand on experience in the end to end of CAPA plans, ensuring timely and effective resolution of compliance risks
Strong working knowledge of global regulatory frameworks (e.g. GXP, FDA, EU IVDR, ISO standards). Experience interpreting and communicating emerging regulations and industry trends affecting diagnostics, devices, and digital health.
You are a credible subject matter expert, confident influencing and partnering with senior stakeholders, and able to provide clear, pragmatic guidance in complex, regulated environments.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
There are currently 144 open science & research positions in Cambridge, United Kingdom listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Riverlane, AstraZeneca, Danaher Corporation, Microsoft, Graphcore, among others. Browse the listings above to see every active employer.
Yes — 93 of the 144 open science & research positions offer remote or hybrid work (9 remote, 84 hybrid).
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