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Danaher Corporation Quality Leader in Cardiff, United Kingdom

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What you’ll do

  • Leads and drives QMS compliance across site and franchises which includes, but is not limited to the following; Production & Process Controls, Corrective and Preventative Actions (CAPA), Change Control, Design Controls, Product Holds/Field Action, Complaint Management, Document Control, Quality Training, Product Release, Internal Auditing

  • Responsible and accountable for quality metrics within the business and management review process.

  • Influences product compliance, process development and New Product Introduction (NPI).

  • Has the authority to issue Concessions, Deviations and stop production.

  • Represents Quality in program and milestone reviews

  • Ensures inspection readiness for assigned area of responsibility.

  • Manages budget and headcount as applicable

  • Drives a continuous improvement culture based on data trends/customer feedback.

  • Positive coaching to teams during periods of business change/growth

  • Foster constructive conflict & collaboration with business partners.

  • Versatility to lead Quality Management systems within regulated & non-regulated environments & support to business integrations as necessary

  • Comprehensive understanding of industry regulations/guidance & health authority regulations (i.e. 21 CFR 820, 210, 211, ISO 9001; ISO 13485; ISO 14644; ICH Q1 -12; EMA/410/01) to support the manufacture & distribution of Cardiff manufactured products

  • Interfacing with Global Regulatory Bodies & Health Authorities

Who you are

  • Bachelor’s degree in a scientific discipline

  • Minimum 8 years Quality Assurance/Regulatory Assurance experience.

  • Minimum of 3 years supervisory/management or project leadership experience

  • Demonstrated significant change management lead expertise

  • Proven process development and project management skills.

  • Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.

  • Experience in a global, matrixed organization structure.

  • Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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