Senior Director QARA Risk Manager Cytiva

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.  You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. This role will architect and lead a global Quality Risk Management (QRM) capability, embedding risk into the Quality Management System (QMS) and across operations. You will leverage AI, data, and advanced analytics to move the organization from reactive response to early signal detection, predictive insight, and proactive risk control. This role leads a global team supporting enterprise risk, analytics, and transformation initiatives across Cytiva.  This position reports to the Group Vice President, QARA Biotechnology, is part of QARA Leadership team.

You will architect and lead a global Quality Risk Management (QRM) capability, embedding risk into the Quality Management System (QMS) and across operations.  Build and develop a high-performing global team with strong capability in risk, analytics, and transformation; further leverage AI, data, and advanced analytics to move the organization from reactive response to early signal detection, predictive insight, and proactive risk control.  Lead a global team supporting enterprise risk, analytics, and transformation initiatives across Cytiva.  Define and deploy a Cytiva-wide Quality Risk Management strategy, aligned to regulatory expectations and business growth & Build and embed a standardized, enterprise QRM framework across QMS, operations, and product lifecycle.   Lead development of a data- and AI-enabled Quality Risk ecosystem, including predictive models and early warning systems. Integrate QMS, manufacturing, supplier, and customer data to drive enterprise-wide risk insight and decision-making and Embed Quality risk into DBS, operating rhythms, and leadership decision-making.   Establish risk-based approaches to deviations, CAPA, audits, and regulatory response, ensuring speed, rigor, and consistency.

Bachelor’s degree in Life science, or relevant industry experience. Minimum 15+ years of experience in Quality Assurance, compliance, or governance, with a strong background in quality risk management and understanding of AI compliance. Working knowledge of ISO 9001. Working knowledge of GAMP and CSV. Familiarity with EU AI Act requirements for deployers and providers, including documentation and conformity processes. Experience implementing risk and compliance controls within quality assurance and IT systems Understanding of data privacy regulations (GDPR) and their intersection with AI governance. It would be a plus if you also possess previous experience in: Experience in regulated industries (life sciences, healthcare, or financial services). Exposure to generative AI risk management and secure SDLC practices for AI-enabled platforms. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel – per business needs Cytiva, a Danaher operating company, offers a broad array of comprehensive,