Associate Director Quality: Digital Therapeutic and Device Process Specialist
AstraZeneca

Join us at AstraZeneca as an Associate Director, Quality - Digital Therapeutic and Device Process Specialist. In this role, you will provide quality engineering expertise, technical guidance, leadership, and direction for digital therapeutic and medical device software products across their life cycle. You will lead initiatives that build and ensure continuous improvement, optimization, and maintenance activities of the life cycle processes supporting our digital therapeutic and medical device software products. This role requires in-depth analysis and collaboration with relevant stakeholders to define, lead, and influence strategies involving complex and diverse issues.

Accountabilities:

As an Associate Director, you will be responsible for the analysis of company device quality requirements and the establishment of systems and procedures to enable compliant delivery of digital therapeutic and medical device software products. You will deliver quality initiatives and improvement programs aimed at building compliance, enhancing commitment to quality, and improving profitability. You will provide expert device knowledge in interpreting device legislation, regulation, and guidelines for digital therapeutic and medical device quality system requirements. You will also represent Device Quality in cross-functional teams across the business.

Essential Skills/Experience:

- Bachelor's degree in engineering or equivalent technical discipline

- Extensive knowledge of both US and international device design life cycle and risk management requirements (specifically IEC 62304, 21 CFR Part 820, ISO 13485, ISO 14971)

- Significant experience in the combination product or medical device industry, with preference for direct experience with medical device software products

- Good understanding based in practice of software testing practices, methodologies and techniques.

- Experience in business process / quality system management.

- Demonstrated track record of successful delivery within a matrix organization.

- Evidence of excellent communication skills building excellent relationships with customers.

- Experience in continuous improvement and process streamlining and optimization.

- Experience working with and leading cross-functional teams.

Preferred Experience:

- Project management experience

- Development experience with combination products including injection and/or inhalation devices

- Experience with health authority interactions and regulatory submissions for device and medical device software products

- Experience applying Lean principles and leading change initiatives within a structured framework.

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 take Quality seriously. We are proactive, science-based, solutions-oriented, and always looking to add real value to our business throughout the lifecycle of our products. We are the voice of the patient, certifying every batch as if the medicine were for our own family. We are a team of ambitious people who are driven to be proactive and solutions-focused. We follow evidence to reach outcomes that benefit patients and AstraZeneca. We work cross-functionally, across sites and regionally, sharing expertise and offering support to others. We are strong communicators and networkers who take personal responsibility for the medicines we certify.

Are you ready to make a difference? Join us at AstraZeneca where we are dedicated to improving the quality of patients' healthcare and ultimately their quality of life!

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.