Head of Quality & Compliance - 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 disruptive, 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. 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. 

As the leader of the Quality and Compliance team, you’ll ensure Evinova’s products and services meet and exceed regulatory requirements.  Your leadership will maintain the highest quality standards, ensuring compliance and driving continuous improvement across our health-tech solutions.

Quality and Compliance Leadership

• Lead the development and improvement of our Quality Management System (QMS) to ensure compliance with regulatory standards such as 21 CFR Part 11, ISO 27001, ISO 9001, ICH GCP, and GAMP5.
• Conduct internal audits to assess compliance with our QMS, and represent Evinova in external audits.
• Provide project document and test review and approval in compliance with our established software development lifecycle (SDLC) requirements.

Audit Management

• Direct responsibility for scheduling, hosting, and following up on all customer audits. Provide responses to customer audit reports and ensure timely closure of resulting corrective actions.
• Conduct vendor audits, including on-site audits if necessary, providing formal reports which enumerate findings and observations, and following up to assure corrective actions are taken.

System and Process Improvement

• Support the implementation and validation of internal computer systems (QMS, Training, CAPA) to support the quality framework, serving as the system administrator for relevant quality-related systems.
• Lead efforts to improve, modify, and grow the corporate QMS to comply with industry and federal regulations and align with corporate strategic goals.

Regulatory Guidance and Training

• Stay abreast of industry and federal regulations, providing guidance and expertise to the global organization in regulatory compliance and quality.
• Provide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision-making related to product development, service delivery, and customer relations.
• Manage the revision and approval of department Quality System Policies and SOPs.
• Guide and enhance training programs across the organization.

About You

• Thrive in collaborative environments, working with peers to overcome challenges and improve processes.
• Adaptable and able to pivot strategies in response to changing business needs.
• Serve as a trusted advisor to product, delivery and other teams, providing expert guidance on quality and compliance requirements.
• Proactively identify and communicate potential compliance risks to cross-functional teams, ensuring early mitigation.

Minimum Qualifications:

• 7-10 years of experience in quality and regulatory compliance, with proven experience developing and managing Quality Processes and QMS.
• Bachelor's degree in a scientific discipline, Computer Science, or a related field. A Master’s degree is a plus.
• Expert in ICH-GCP guidelines, CFR Title 21, Part 11, and delivering GxP and SaMD solutions.
• Experience working in a global organization with complex, geographical contexts.
• Experience conducting internal audits or managing external audits as an auditee.
• Strong knowledge of software development and testing processes, especially Agile development.
• Ability to understand high-level technical concepts and provide insightful reviews and commentary on project documents.
• Excellent written communication skills in English.
• Famili