Director, Quality Assurance (Diagnostics & Devices)

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 worlds most serious diseases. But were more than one of the worlds 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.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!!

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 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.

In Office Requirement:

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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.

Date Posted

Closing Date