Sr Director, Head of Quality and Compliance – Evinova - null

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Description : Sr Director, Head of Quality and Compliance – Evinova. Company : null. Location :

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 health-tech business part of the AstraZeneca Group might be for you!

Transform billions of patients’ lives through technology, data, and pioneering, ways of working. You’re disruptive, decisive, and transformative. Someone who’s 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 impactful digital solutions that improve the patient experience and deliver better health outcomes. Together, we have the opportunity to combine deep scientific expertise with digital and artificial intelligence to serve the wider healthcare community and create new standards across the sector.

The Head of Quality and Compliance will establish and oversee the Evinova’s quality management and compliance strategy, policies, procedures and operations. They will be responsible for the initial accreditation and ongoing maintenance of essential certifications including GAMP Software Category 5 (GxP), ISO 27001, ISO 13485, SOC-2, ICH GCP, FDA 21 CFR Part 11, and HIPAA. The role will collaborate closely with the Head of Cyber Security and Head of Data Privacy to ensure compliance with NIST Cyber Security Framework (CSF), NIST SP 800-53, EU GDPR, France CNIL, China PIPL, Russia 152-FZ and other relevant information security and data privacy 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.

  • Leads the Quality and Compliance function with a clear mandate to deliver a high-quality, compliant set of products and services to customers globally

  • Drives the overall development, implementation and operational oversight of quality and compliance strategy, policies and procedures collaboratively with the Privacy, Cyber Security, Product, Tech, and Science functions

  • Promotes and enforces compliance with established quality systems, operating procedures and proactively leads change as external regulations and best practices emerge

  • Leads end-to-end efforts for external accreditation/certifications, customer qualification audits, routine customer audits, and routine health authority inspections

  • Oversees the tactical implementation of leadership decisions and ensures alignment with desired outcomes.

  • Provides senior-level assurance and attestation of product validation status and overall externally-regulated compliance status

  • Champions innovative approaches to quality and compliance both internally and externally with clearly established key performance indicators (critical metrics), objectives for continuous improvement, and long-term strategic goals emphasizing automation, efficiency, and proactive risk management

  • Embraces a customer-centric, impactful, right problem / right solution engineering approach and culture.

  • Handles and balances legal risk by understanding current and emerging industry regulations and taking proactive action to modify internal quality and compliance policies and procedures

  • Establishes baseline metrics and actively optimizes the cost profile of Quality and Compliance as a percentage of revenue and minimizes the process burden for ongoing product development and service delivery

  • Continuously updates knowledge by participating in educational opportunities, reading professional publications, and participating in professional organizations

  • Actively participates 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:

  • BA/BSc and extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment

  • 10 years of proven experience

  • Knowledge of industry good practices and standards such as ISO (multiple), GAMP GxP, ICH GCP, FDA 21 CFR, GDPR, CMMI, ITIL, GDPR

  • Direct experience leading quality teams in a software product company environment

  • Developing quality, compliance and risk strategies and articulating the strategic direction for regulated organizations at all levels

  • Design and implementation of Quality Systems as integral to an overall business strategy

  • Leading diverse groups of senior quality, compliance, and business collaborators with varied and often conflicting priorities

  • Establishing and running Quality and Compliance organizations

  • Continuous improvement/Compliance Improvement

  • External Advocacy representing global organizations and collaborating with quality/compliance/risk-related external industry forums/trade associations

  • Setting Standards by translating regulatory requirements and expectations into ‘fit for purpose’ internal policies and standards for effective business controls

  • Driving risk, quality and compliance assurance across multiple aspects of global operations

  • Internal auditing and external regulatory inspection management

  • Broad IT management experience including project or service management

  • Familiarity with technical concepts in infrastructure or applications

  • External qualifications such as ISPE PCC CPIP and ISACA CISM

Desired Qualifications:

  • Ability to drive innovation in a Compliance and Quality environment

  • Proven challenge, negotiation & influencing capabilities

  • Strong Change Management Leadership

  • Tight-knit collaboration and relationship-building skills with both internal and external partners

  • Strong people development skills, attracting talent, and investing in the long-term development of others

  • Highly constructive and enabling coach

  • Presentation, Communication, and facilitation skills

  • Strong leader, drives accountability and inspires the organization to do the right thing

  • Pragmatic decision making - analyses highly sophisticated situations, assessing risks and balancing strategic and tactical compliance/quality requirements

  • Tenacity - challenges the status quo by surfacing challenging and sophisticated issues to get simple and desirable outcomes

  • Ability to stay calm under pressure

  • Actively identifies untapped opportunities and drives benefit realization.

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?

  • 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