Company

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.

The Senior QARA Customer Operations Manager will partner internally and globally with external stakeholders to manage world-class Quality Assurance program to met key customer expectations and enhance growth. Reporting into the APAC QA leader for Cytiva, but following global standard work, the candidate will also support the Korea commercial team and Global Strategic Account Manager.

This position reports to the Quality Director – Equipment Services and Global Strategic Accounts and is part of the Global Quality Assurance and Regulatory Affairs. The role can be located at any Cytiva location in the UK or Europe.

What you'll do

Leading QA activities related to strategic customer requests, including:

• Partnering with Commercial leaders as a single point of contact for Strategic Customers, resolving Quality and Regulatory issues, and facilitating interactions with local and global teams.
• Setting and monitoring customer Quality KPIs, reporting on performance and trend insights during business reviews.
• Driving efficiencies and improvements through DBS to provide excellent customer support.

In total, this Associate will be responsible for:

• Engaging deeply with customers to understand trends, build relationships, and address queries and complaints.
• Managing daily interactions with stakeholders and customers to ensure accountability and governance, aligning closely with commercial teams.
• Developing action plans with internal stakeholders and customers to enhance satisfaction and experience.
• Handling high urgency cases and escalations for customers, clearly communicating with stakeholders.
• Setting up and managing Quality Agreements and supporting regulatory document requests to delight customers.

Who you are

• Bachelor's degree and minimum 5+ years' work experience in a Quality or Regulatory Assurance related field including Biopharma or Life Sciences.
• Experience in Customer relationship management is a must. Project/Program Management skills would be desirable.
• The ability to identify, prioritize, and solve problems is essential. This involves understanding customer inquiries and providing solutions that meet their needs.
• Knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820 and ISO 13485, MDR, MD-SAP and other relevant country specific requirements.
• Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization, and external stakeholders. Demonstrated understanding of root cause analysis, corrective and preventive action (CAPA), change control, verification and validation methodologies, manufacturing/production process control methodologies, and continuous improvement.
• Strong interpersonal skills and ability to communicate complex information effectively (both written and oral). Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
• Aware of and comply with the Cytiva Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. Complete all planned Quality & Compliance training within the defined deadlines.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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