Good Clinical Practice Quality Director - Evinova

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

Transform billions of patients’ lives through technology, data and cutting-edge ways of working. You’re innovative, decisive and transformative. Someone who’s excited to use technology to improve patients’ health. We’re building a new healthtech 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 Good Clinical Practice (GCP) Senior Quality Manager will be responsible for ensuring that Evinova clinical trial solutions are developed, implemented and operationally supported in accordance with relevant global regulations including ICH and FDA guidelines. 

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 GCP oversight and support to the development, implementation, continuous improvement, and maintenance 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
• Provide Good Clinical Practice (GCP) 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
• Provide Good Clinical Practice (GCP) subject matter expertise as direct input to the Evinova software development lifecycle, providing end-to-end GCP oversight of the software design and release processes in alignment with the Evinova quality system
• Guide, support and validate Evinova software implementation, operations and support practices and teams in accordance with GCP guidelines
• Perform training and education internally in global GCP standards, and externally as required (Investigator Meetings, CRA Trainings, Pre-Approval Inspections, etc.)
• 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 GCP quality objectives
• Promote and enforces compliance with established quality systems, operating procedures and proactively manages change as external regulations and standard methodologies emerge
• Oversee the operational implementation of leadership decisions and ensures alignment with desired outcomes in relation to Evinova’s Quality and Compliance strategy specifically in relation to GCP
• 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 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
• Coordinate with study team and/or solution implementation teams members to ensure vendor audits are appropriately scoped and that third-party auditors are provided all the documentation and insights required for successful audit execution
• Work with internal and external customers to develop and complete strategic plans to identify, mitigate, monitor, and report GCP study risks on a per study basis where required
• Other duties as assigned

Minimum Qualifications:

• Bachelor’s Degree
• A minimum of 10 years of experience in the pharmaceutical industry
• Strong knowledge of global GCP/GMP regulations, guidance, and standards
• 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.)
• Assist with the preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses
• Experience in the planning, identification, coordination, execution, reporting and closure of GCP Compliance issues including audit findings and CAPAs in support of clinical programs
• Experience in GCP auditing, implementation of risk based GCP and compliance oversight
• Experience in representing GCP QA in assigned weekly protocol project team meetings
• Thorough knowledge of applicable local and global regulatory requirements required for GCP/GMP compliance
• Planning and performing software quality assurance for mobile cloud solutions supporting clinical trails
• Experience in conducting qualification or routine vendor audits of Clinical Research Organizations, Clinical Laboratories, Phase I Units, Imaging Vendors, eTMF Vendors, Investigator Sponsored Trials Assist in the management and closure of GCP CAPAs, including metrics tracking and reporting
• Experience in conducting Regulatory Submission Review such as Investigator Brochures (IB), Development Safety Update Report (DSUR), Clinical Study Reports (CSRs), NDAs, Clinical Protocols

Desireable 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 collaborators
• 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
• Ability to work in a team environment across multiple sites

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 their 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  healttech business to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering innovative 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?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

• Learn more about Evinova www.evinova.com

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.