SaMD Senior Quality Director - Evinova

Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges?  Then Evinova, a new health tech business part of the AstraZeneca Group might be for you!   

Transform billions of patients’ lives through technology, data, and innovative ways of working. You’re ground-breaking, decisive, and transformative. Someone excited to use technology to improve patients’ health. We’re building a new Health-tech business – Evinova, a fully-owned subsidiary of AstraZeneca Group. 

Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping. Launch pioneering digital solutions that improve the patients’ experience and deliver better health outcomes.

The Software as a Medical Device (SaMD) Senior Quality Manager will be responsible for ensuring that SaMD products produced for Evinova are designed, developed, and released in compliance with worldwide regulations including US and EU regulations. 

The expectations of the role will expand with the maturity of the Evinova business with a clear focus on delivering high quality, compliant products and services with industry-leading, highly-automated and efficient practices. This includes active participation in external industry forums, consultation and engagement with regulators, and collaboration with customers pre and post-sales. The role will represent the company in vendor qualification, routine audits, and health authority inspections where applicable.  

This role presents an opportunity to join Evinova from the beginning, designing and implementing new, innovative approaches to Quality and Compliance that are designed by industry, for industry with the following responsibilities: 

• Provide oversight and support the development, implementation, continuous improvement of the Evinova Quality Management System that meets the requirements of the GxP, GcP, GmP, FDA's QSR, MDD, ISO 13485 and other standards as required
• Guide and support software design and releas processes in alignment with the Evinova quality syste, including design reviews, engineering reviews, and device change control
• Work with the internal audit system group to ensure continued compliance to domestic and international regulatory regulations
• Work closely with the company’s Quality, Audit and Operations teams to ensure local procedures and performance are consistent with company’s quality objectives
• Promotes and enforces compliance with established quality systems, operating procedures and proactively manages change as external regulations and standard processes emerge
• Oversee the operational implementation of leadership decisions and ensures alignment with desired outcomes in relation to Evinova’s Quality and Compliance strategy
• Embrace a customer-centric, hard-working, right problem / right solution engineering approach and culture.
• Manage and balances legal risk by understanding current and emerging industry regulations and take proactive action to modify internal quality and compliance policies and procedures
• Continuously update knowledge by participating in educational opportunities, reading professional publications and participating in professional organizations
• Actively participate in product strategy and roadmap development, ensuring quality and compliance requirements are represented and balanced with new capability development
• Other duties as assigned

Minimum Qualifications:

• Bachelor’s Degree
• A minimum of 10 years of experience in biomedical device industry and/or relevant biopharma industry experience
• Experience in design control, software validation, and safety assurance cases
• Experience in developing medical device or pharmaceutical Quality Systems in a regulated environment and generation of Standard Operating Procedures and Work Instructions
• Experience with SaMD development, verification/validation of mobile, cloud base solutions 
• Experience with supporting Health Authority Inspections (FDA, EMA, etc.)
• Proven ability in preparing for and managing quality and/or regulatory inspections, and supplier assessments for SaMD products
• Quality Management System Training: ISO 13485:2016
• Ability to work in a team environment across multiple sites
• Detailed knowledge of applicable local and global regulatory requirements required for SaMD compliance for worldwide distribution
• Experience in complex medical product development and design verification & validation in accordance with 21 CFR 820.30 (design controls)
• Knowledge of software development and verification, validation, and testing strategies as detailed in FDA Design Controls 21CFR820, FDA Guidelines, ISO-13485, ISO-62304, and ISO-14971
• Knowledge and generation of required artifacts for stage gate design reviews
• Proven track record of releasing FDA & EU moderate to high-risk medical devices with extensive knowledge of the complete software development life cycles from requirement capture, development, product release and post-market surveillance of the released product
• Knowledge of Risk Control measures and mitigations including generations of risk artifacts such as plans, FMEA, FTA, Hazard mitigations and reports per ISO-14971:2019
• Knowledge of Human Factors / Usability Engineering per IEC-62336, including Formative, Summative, clinical protocol generation, and clinical validation
• Knowledge of Cybersecurity Control measures, threat assessment and mitigations including generations of cybersecurity artifacts such as plans, mitigations and reports per FDA’s Guidance documents
• SaMD team training delivery for such areas of the QMS, Risk Management, Cybersecurity, regulated software development and V&V
• Knowledge of software verification, validation, and testing strategies and research for development (training and validation), tuning, and deployment of predictive machine learning models/algorithms in a medical device
• Extensive audit preparation strategies and experience with regulatory agencies and onsite inspections for FDA, BSI, TUV, etc. inspections, presentations, briefings, and responses including setup and support of Front room and Backrooms with effective remediation of artifacts

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.