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 Quality Operations & Audit Senior Manager will be responsible for building and overseeing the framework, processes, and tools needed to support Evinova's Quality and Software Compliance programs. The role will be responsible for performance of the Evinova Quality Program supporting internal audit, customer qualification and periodic audits, and Health Authority Inspections.
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 Software Compliance that are designed by industry, for industry with the following responsibilities:

• Operationally manage Evinova Quality & Software Compliance activities, working cross-functionally with Product Development, Cyber Security, Data Privacy, Legal and Corporate Compliance
• Lead Evinova's Audit & Inspection-Readiness strategy and implementation to support new customer qualification, periodic/routine customer audits and health inspections including audit planning, preparation, management and post-audit reporting and follow-up activities
• Assess audit responses and collaborate with colleagues to develop and ensure closure of audit issues
• Provide audit oversight and support to the development, implementation, continuous improvement, and maintenance of the Evinova Quality Management System that meets the requirements of the GxP, Google Cloud Platform, GmP, FDA's QSR, MDD, ISO 13485 and other standards as required
• Develop and maintain the audit system (within the Evinova eQMS solution) to record the status of all audits and associated actions
• Provide periodic reports to management based on the audit statuses and defined metrics
• Lead planning efforts and conduct of the internal audit program
• Define appropriate critical metrics to monitor the efficiency of the audit program and conducts routine quality and effectiveness reviews
• Monitor and collaborate with GxP & SaMD product development teams to ensure continued compliance to domestic and international regulatory regulations
• Promote and enforce compliance with established quality systems, operating procedures and proactively manage change as external regulations and standard methodologies emerge
• Manage and balance legal risk by understanding current and emerging industry regulations, taking 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

Minimum Qualifications:

• Bachelor's degree required
• A minimum of 10 years of experience in the pharmaceutical/medical device industry
• ISO 13485:2016 Auditor certification (or similar auditor certification)
• ISO 13485:2016 Lead Auditor certification (or similar auditor certification)
• Experience in conducting qualification or routine audits of Clinical Research Organizations, Clinical Laboratories
• Experience in conducting/leading Internal System, process, and documentation Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs
• Audit 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 Frontroom/Backroom with effective remediation of artifacts
• Knowledge and understanding covering a wide range of medical device or healthcare technologies and/or products with direct experience in the design, research, development, manufacturing, processing, testing, servicing, installation, maintenance, auditing, conducting of clinical trials of pharmaceutical/medical device, or work in carrying out inspections, clinical evaluations and experimental and/or clinical research
• Excellent solid understanding of medical device management systems, medical device compliance and auditing techniques ensuring compliance to worldwide regulatory requirements such as (e. g., FDA, MDR (EU 2017/745), local procedures, and corporate policies/procedures
• Extensive solid understanding of current FDA, EU, MDSAP and other global regulation and guidance governing Good Manufacturing Practice (GMP), Good Clinical Practice (Google Cloud Platform) and Good Distribution Practice (GDP) activities
• Experience in developing pharmaceutical or medical device Quality Systems in a regulated environment and generation of Standard Operating Procedures and Work Instructions
• Experience with supporting Health Authority Inspections (FDA, EMA, etc.) for FDA SaMD Class II/III
• Leading the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses
• Ability to work in a team environment across multiple sites
• Planning and performing software quality assurance tasks for mobile cloud solutions supporting clinical trails with the generation of plans, reports, etc.
• Working closely with R&D, Clinical, CROs, suppliers, and customer support teams to address audit issues swiftly and effectively
• Audit experience working with Contract Organizations, Service Providers, and other entities which provide contracted services

Desired Qualifications:

• Ability to drive innovation in a Compliance and Quality environment
• Proven challenge, negotiation & influencing capabilities
• Strong change management leadership
• Strong collaboration and relationship building skill with both internal and external customers
• Strong people development skills, attracting talent and investing in long-term development of others
• Highly constructive and enabling coach
• Presentation, Communication & Facilitation skills
• Strong leader, drives accountability and inspires the organization to do the right thing
• Pragmatic decision making - analyses highly complex situations, assessing risks and balancing strategic and tactical compliance/quality requirements
• Tenacity - challenges the status quo by surfacing challenging and complex issues to get simple and desirable outcomes
• Ability to stay calm under pressure
• Actively identifies untapped opportunities and drives benefit realisation

Why Evinova (AstraZeneca)?
Evinova draws on AstraZeneca's deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health tech business to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
Where can I find out more?
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Learn more about Evinova
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.