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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 rolewill architect and lead a global Quality Risk Management (QRM) capability embedding risk into the Quality Management System (QMS) and across will leverage AI data and advanced analytics to move the organization from reactive response to early signal detection predictive insight and proactive risk 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.

What you will do:

• 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.

Who you are:

• Bachelors 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 competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is 140000 - 170000 GBP. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note:

No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe…