Director, Quality Assurance (Diagnostics & Devices)
Cambridge, UK (3 days on site per week)
About AstraZeneca
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.
Key Responsibilities
Audit & Assurance Delivery
- 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
Strategic Leadership, Advisory & Stakeholder Influence (Accountabilities)
- 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
Requirements
- A degree (or equivalent experience) and 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
- Hands‑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
In Office Requirement
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 is 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.
Competitive salary and benefits package on offer
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.
Equal Opportunities
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustmentsaccommodations to help all candidates to perform at their best. If you have a need for any adjustmentsaccommodations, please complete the section in the application form.
