Director, Device Quality

Job Title: Director, Device Quality

Introduction to role

Are you a quality professional with significant expertise in Medical Device and Combination Product quality system requirements? Join us to ensure our quality systems, process and procedures remain compliant, scalable, effective, and efficient.

Drawing on your experience across the full device product life cycle, you will enhance our approach to quality and quality management systems globally.  You’ll lead initiatives that ensure continuous improvement, optimization, and maintenance activities of the device life cycle processes and be an SME partner across the business.

Accountabilities

• Quality Business Process Owner for the device design process. BPO accountabilities include:

  • Design and own the global standards and procedures for the area, ensuring all meet regulatory requirements.

  • Engage and lead a global process network.

  • Provide subject matter expertise and coaching.

  • Define and manage a program of continuous improvement.

  • Manage links and interdependencies with other processes and BPOs, collaborating to align and integrate processes and systems across the Pharmaceutical Quality System.

  • Facilitate sharing and adoption of good practices & learning.

  • Responsible for inspection defence and observation responses related to the process and applicable regulations.

  • Actively monitor the external environment for potential trends and changes in cGMP expectations, new or revised regulatory requirements, industry guidance documents issues or trends.

  • Identify, calibrate, and manage risks, raising when needed.

  • Lead global projects or programs where required to deliver Quality transformation and strategy.

• Provide expert knowledge in interpreting device legislation, regulation, and guidelines.

• Represent Device Quality as required in cross-functional teams across the business.

• SME for device audits/inspections, may lead or host audits.

• Partner with other functions to support device knowledge and capability build.

• Stay current on industry standards, quality management, and new developments to improve your understanding.

Essential Skills/Experience

• Bachelor’s degree in engineering or equivalent experience in a technical field

• Experience in multiple areas of Quality within a pharmaceutical environment

• Demonstrated experience in business process / quality system creation and management in a regulated environment

• Significant Subject Matter Expertise in device design life cycle and risk management requirements (specifically ISO13485, EU MDR, 21 CFR Part 820, ISO 14971)

• Device product-facing experience across the design, development, and on-market life cycle

• Demonstrated track record of successful delivery within a matrix organization

• Ability to influence and define global way of working

• Strong risk-based decision-making skills

• Experience of hosting device audits

• Evidence of excellent communication skills building strong relationships with partners and customers

Desirable Skills/Experience

• Practical implementation of Medical Device requirements within a pharmaceutical company

• MDSAP / ISO 13485 audit readiness preparation

• Experience in leading transformational change programs across global Quality Control networks

• Ability to assess trends, complex data sets, and generate robust arguments and impact analysis

• Subject Matter Expertise in EU IVDR, IEC 62304 with knowledge of Medical Device software development

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.

At AstraZeneca, we are driven by a forward-looking mindset that values innovation and excellence. Our commitment to quality is unwavering as we strive to add real value throughout the lifecycle of our products. We empower our team members to make brave decisions, follow scientific evidence, and prioritize patient outcomes. Working here means being part of an inclusive community where every voice matters, fostering collaboration across functions to achieve our ambitious goals.

Ready to make a difference? Apply now to join our team!

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 authorisation and employment eligibility verification requirements.